Trial Outcomes & Findings for Study to Evaluate VORTX Rx (Theresa) (NCT NCT03741088)
NCT ID: NCT03741088
Last Updated: 2021-04-20
Results Overview
Number of Lesions that were Successfully Ablated according to technical success definition established in the protocol.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
1-day post ablation
Results posted on
2021-04-20
Participant Flow
Unit of analysis: Lesions
Participant milestones
| Measure |
VORTX Rx Treatment
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Overall Study
STARTED
|
8 11
|
|
Overall Study
COMPLETED
|
5 6
|
|
Overall Study
NOT COMPLETED
|
3 5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate VORTX Rx (Theresa)
Baseline characteristics by cohort
| Measure |
VORTX Rx Treatment
n=8 Participants
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 13.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Spain
|
8 participants
n=99 Participants
|
|
Type of live tumors
Hepatocellular carcinoma
|
1 Participants
n=99 Participants
|
|
Type of live tumors
Liver metastasis
|
7 Participants
n=99 Participants
|
|
Body Mass Index (BMI)
|
25.1 kg/m^2
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 0
|
2 Participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 1
|
6 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1-day post ablationNumber of Lesions that were Successfully Ablated according to technical success definition established in the protocol.
Outcome measures
| Measure |
VORTX Rx Treatment
n=11 lesions
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Acute Technical Performance of the VORTX Rx® Medical Device for the Ablation of Primary and Metastatic Liver Tumors
|
11 lesions
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Although only 5 participants performed all protocol visits, adverse events from all patients were reported and analyzed. Any of the 55 AEs reported was device-related.
Number of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related
Outcome measures
| Measure |
VORTX Rx Treatment
n=55 Adverse Events
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Safety Profile of the VORTX Rx. Incidence of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related
|
0 Adverse Events
|
SECONDARY outcome
Timeframe: 1 week, 1 month and 2 months post-procedure.Number of patients who have indicated local tumor progression in at least one visit (1 week, 1 month, 2 months) for each tumor ablated. The ablation zone will be assessed post-procedurally to evaluate local tumor progression by contrast-enhanced MRI imaging
Outcome measures
| Measure |
VORTX Rx Treatment
n=8 Participants
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Local Tumor Progression
Progression: YES
|
2 Participants
|
|
Local Tumor Progression
Progression: NO
|
5 Participants
|
|
Local Tumor Progression
Progression: No data
|
1 Participants
|
SECONDARY outcome
Timeframe: 24hours, 1 week, 1 month and 2 months, post-procedure.The involution of the ablation zone will be assessed post-procedurally by contrast-enhanced MRI imaging at 24h, 1 week, 1 month and 2 months
Outcome measures
| Measure |
VORTX Rx Treatment
n=6 lesions
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Involution of the Ablation Zone
Ablation zone volume (cm3): 24 hours
|
10.5500 cubic centimeters
Standard Deviation 6.34405
|
|
Involution of the Ablation Zone
Ablation zone volume (cm3): 1 week
|
8.5000 cubic centimeters
Standard Deviation 9.56682
|
|
Involution of the Ablation Zone
Ablation zone volume (cm3): 1 month
|
5.9383 cubic centimeters
Standard Deviation 10.02174
|
|
Involution of the Ablation Zone
Ablation zone volume (cm3): 2 months
|
4.7683 cubic centimeters
Standard Deviation 9.47795
|
SECONDARY outcome
Timeframe: Screening, 24 hours, 1 week, 1 month and 2 months.Population: Only 4 patients have these parameters determined in all study points (screening, 24h, 1 day, 1 month and 2 months post-ablation)
Liver panel will be evaluated on the basis of the change of aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, gamma glutamyl transpeptidase (GGT) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure.
Outcome measures
| Measure |
VORTX Rx Treatment
n=4 ablation procedures
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Assessment of Liver panel_Part 1
AST Screening
|
60.7500 U/L
Standard Deviation 33.83662
|
|
Assessment of Liver panel_Part 1
AST 24 hours
|
183.5000 U/L
Standard Deviation 80.71555
|
|
Assessment of Liver panel_Part 1
AST 1 week
|
47.0000 U/L
Standard Deviation 25.17936
|
|
Assessment of Liver panel_Part 1
AST 1 month
|
40.7500 U/L
Standard Deviation 10.68878
|
|
Assessment of Liver panel_Part 1
AST 2 months
|
40.5000 U/L
Standard Deviation 19.94158
|
|
Assessment of Liver panel_Part 1
ALT Screening
|
44.0000 U/L
Standard Deviation 22.13594
|
|
Assessment of Liver panel_Part 1
ALT 24 hours
|
139.0000 U/L
Standard Deviation 56.12486
|
|
Assessment of Liver panel_Part 1
ALT 1 week
|
58.5000 U/L
Standard Deviation 30.27100
|
|
Assessment of Liver panel_Part 1
ALT 1 month
|
27.5000 U/L
Standard Deviation 12.60952
|
|
Assessment of Liver panel_Part 1
ALT 2 months
|
30.0000 U/L
Standard Deviation 15.55635
|
|
Assessment of Liver panel_Part 1
GGT Screening
|
127.2500 U/L
Standard Deviation 105.05673
|
|
Assessment of Liver panel_Part 1
GGT 24 hours
|
118.0000 U/L
Standard Deviation 111.48692
|
|
Assessment of Liver panel_Part 1
GGT 1 week
|
159.7500 U/L
Standard Deviation 176.57364
|
|
Assessment of Liver panel_Part 1
GGT 1 month
|
162.5000 U/L
Standard Deviation 139.50986
|
|
Assessment of Liver panel_Part 1
GGT 2 months
|
102.5000 U/L
Standard Deviation 43.23964
|
|
Assessment of Liver panel_Part 1
Alkaline Phosphatase Screening
|
156.5000 U/L
Standard Deviation 139.89639
|
|
Assessment of Liver panel_Part 1
Alkaline Phosphatase 24 hours
|
127.2500 U/L
Standard Deviation 67.14847
|
|
Assessment of Liver panel_Part 1
Alkaline Phosphatase 1 week
|
165.0000 U/L
Standard Deviation 88.67168
|
|
Assessment of Liver panel_Part 1
Alkaline Phosphatase 1 month
|
146.7500 U/L
Standard Deviation 66.33941
|
|
Assessment of Liver panel_Part 1
Alkaline Phosphatase 2 months
|
130.2500 U/L
Standard Deviation 74.44629
|
SECONDARY outcome
Timeframe: 24 hours, 1 week and 1 month and 2 monthsPopulation: Only 4 patients have these parameters determined in all study points (screening, 24h, 1 day, 1 month and 2 months post-ablation)
Liver panel will be evaluated on the basis of the change of albumin from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure.
Outcome measures
| Measure |
VORTX Rx Treatment
n=4 ablation procedures
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Assessment of Liver Panel_Part 2
Albumin 1 month
|
39.3750 g/L
Standard Deviation 0.63966
|
|
Assessment of Liver Panel_Part 2
Albumin Screening
|
40.0250 g/L
Standard Deviation 2.88603
|
|
Assessment of Liver Panel_Part 2
Albumin 24 hours
|
34.7500 g/L
Standard Deviation 1.13284
|
|
Assessment of Liver Panel_Part 2
Albumin 1 week
|
37.5250 g/L
Standard Deviation 1.95683
|
|
Assessment of Liver Panel_Part 2
Albumin 2 months
|
40.1750 g/L
Standard Deviation 1.65806
|
SECONDARY outcome
Timeframe: 24 hours, 1 week and 1month and 2 monthsLiver panel will be evaluated on the basis of the change of bilirubin from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure
Outcome measures
| Measure |
VORTX Rx Treatment
n=4 ablation procedures
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Assessment of Liver Panel_Part 3
Total Bilirrubin Screening
|
0.7525 mg/dL
Standard Deviation 0.42578
|
|
Assessment of Liver Panel_Part 3
Total Bilirrubin 24 hours
|
0.6425 mg/dL
Standard Deviation 0.20549
|
|
Assessment of Liver Panel_Part 3
Total Bilirrubin 1 week
|
0.7600 mg/dL
Standard Deviation 0.32934
|
|
Assessment of Liver Panel_Part 3
Total Bilirrubin 1 month
|
0.5250 mg/dL
Standard Deviation 0.11561
|
|
Assessment of Liver Panel_Part 3
Total Bilirrubin 2 months
|
0.7050 mg/dL
Standard Deviation 0.31268
|
SECONDARY outcome
Timeframe: 24 hours, 1 week and 1month and 2 monthsPopulation: Only 4 patients have these parameters determined in all study points (screening, 24h, 1 day, 1 month and 2 months post-ablation)
Liver panel will be evaluated on the basis of the change of prothrombin time (PT) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure
Outcome measures
| Measure |
VORTX Rx Treatment
n=4 ablation procedures
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Assessment of Liver Panel_part 4
Prothrombin time 1 month
|
98.7500 percentage of activity
Standard Deviation 2.50000
|
|
Assessment of Liver Panel_part 4
Prothrombin time Screening
|
95.2500 percentage of activity
Standard Deviation 5.50000
|
|
Assessment of Liver Panel_part 4
Prothrombin time 24 hours
|
92.5000 percentage of activity
Standard Deviation 9.94987
|
|
Assessment of Liver Panel_part 4
Prothrombin time 1 week
|
92.7500 percentage of activity
Standard Deviation 8.38153
|
|
Assessment of Liver Panel_part 4
Prothrombin time 2 months
|
91.2500 percentage of activity
Standard Deviation 17.50000
|
SECONDARY outcome
Timeframe: 24 hours, 1 week and 1 month and 2 monthsLiver panel will be evaluated on the basis of the change of International normalized ratio (INR = A system established by the World Health Organization (WHO) and the International Committee on Thrombosis and Hemostasis for reporting the results of blood coagulation (clotting) tests) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure. The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Patient PT ÷ Control PT. Normal values for INR: 0.9-1.3.
Outcome measures
| Measure |
VORTX Rx Treatment
n=4 ablation procedures
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Assessment of Liver Panel_Part 5
INR Screening
|
1.0500 ratio
Standard Deviation 0.5774
|
|
Assessment of Liver Panel_Part 5
INR 24 hours
|
1.0750 ratio
Standard Deviation 0.09574
|
|
Assessment of Liver Panel_Part 5
INR 1 week
|
1.0500 ratio
Standard Deviation 0.05774
|
|
Assessment of Liver Panel_Part 5
INR 1 month
|
1.0250 ratio
Standard Deviation 0.05000
|
|
Assessment of Liver Panel_Part 5
INR 2 months
|
1.0750 ratio
Standard Deviation 0.15000
|
SECONDARY outcome
Timeframe: Baseline/Screening, 1-day post ablation, 1 week and 1 and 2 months post procedureImmunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests: CD3+, CD4+, CD8+, CD45+, CD16+, CD56+ and CD19+ from Baseline/Screening to 1-day post ablation, 1 week and 1 and 2 months post procedureprocedure.
Outcome measures
| Measure |
VORTX Rx Treatment
n=4 ablation procedures
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Immunologic Assessment_Part 1
CD4+ (T helper cells) 1 week
|
445.2500 cells/uL
Standard Deviation 121.94637
|
|
Immunologic Assessment_Part 1
CD4+ (T helper cells) 1 month
|
357.0000 cells/uL
Standard Deviation 159.34240
|
|
Immunologic Assessment_Part 1
CD4+ (T helper cells) 2 months
|
382.2500 cells/uL
Standard Deviation 77.24150
|
|
Immunologic Assessment_Part 1
CD3+ (T cells) 2 months
|
632.0000 cells/uL
Standard Deviation 150.53017
|
|
Immunologic Assessment_Part 1
CD56+ (NKT cells) 1 month
|
63.2500 cells/uL
Standard Deviation 68.07533
|
|
Immunologic Assessment_Part 1
CD56+ (NKT cells) 2 months
|
60.7500 cells/uL
Standard Deviation 50.12900
|
|
Immunologic Assessment_Part 1
CD19+ (B-lymphocyte antigen) Screening
|
85.0000 cells/uL
Standard Deviation 58.66856
|
|
Immunologic Assessment_Part 1
CD19+ (B-lymphocyte antigen) 24 hours
|
83.5000 cells/uL
Standard Deviation 58.31238
|
|
Immunologic Assessment_Part 1
CD19+ (B-lymphocyte antigen) 1 week
|
86.5000 cells/uL
Standard Deviation 53.10053
|
|
Immunologic Assessment_Part 1
CD3+ (T cells) Screening
|
801.7500 cells/uL
Standard Deviation 374.33708
|
|
Immunologic Assessment_Part 1
CD3+ (T cells) 24 hours
|
618.2500 cells/uL
Standard Deviation 365.48814
|
|
Immunologic Assessment_Part 1
CD3+ (T cells) 1 week
|
713.7500 cells/uL
Standard Deviation 234.09596
|
|
Immunologic Assessment_Part 1
CD3+ (T cells) 1 month
|
587.7500 cells/uL
Standard Deviation 253.11575
|
|
Immunologic Assessment_Part 1
CD4+ (T helper cells) Screening
|
469.2500 cells/uL
Standard Deviation 146.20619
|
|
Immunologic Assessment_Part 1
CD4+ (T helper cells) 24 hours
|
374.7500 cells/uL
Standard Deviation 128.99709
|
|
Immunologic Assessment_Part 1
CD8+ (T suppressor/cytotoxic cells) Screening
|
262.7500 cells/uL
Standard Deviation 223.82638
|
|
Immunologic Assessment_Part 1
CD8+ (T suppressor/cytotoxic cells) 24 hours
|
220.5000 cells/uL
Standard Deviation 204.31593
|
|
Immunologic Assessment_Part 1
CD8+ (T suppressor/cytotoxic cells) 1 week
|
230.5000 cells/uL
Standard Deviation 139.01679
|
|
Immunologic Assessment_Part 1
CD8+ (T suppressor/cytotoxic cells) 1 month
|
186.7500 cells/uL
Standard Deviation 136.19196
|
|
Immunologic Assessment_Part 1
CD8+ (T suppressor/cytotoxic cells) 2 months
|
177.2500 cells/uL
Standard Deviation 85.47660
|
|
Immunologic Assessment_Part 1
CD45+ (leucocyte common antigen) Screening
|
1054.1425 cells/uL
Standard Deviation 384.46746
|
|
Immunologic Assessment_Part 1
CD45+ (leucocyte common antigen) 24 hours
|
843.0350 cells/uL
Standard Deviation 349.94733
|
|
Immunologic Assessment_Part 1
CD45+ (leucocyte common antigen) 1 week
|
938.3700 cells/uL
Standard Deviation 251.60549
|
|
Immunologic Assessment_Part 1
CD45+ (leucocyte common antigen) 1 month
|
788.4275 cells/uL
Standard Deviation 257.71702
|
|
Immunologic Assessment_Part 1
CD45+ (leucocyte common antigen) 2 months
|
831.2675 cells/uL
Standard Deviation 194.76464
|
|
Immunologic Assessment_Part 1
CD16+ Screening
|
134.3000 cells/uL
Standard Deviation 69.78811
|
|
Immunologic Assessment_Part 1
CD16+ 24 hours
|
78.4750 cells/uL
Standard Deviation 50.40353
|
|
Immunologic Assessment_Part 1
CD16+ 1 week
|
116.1750 cells/uL
Standard Deviation 65.72460
|
|
Immunologic Assessment_Part 1
CD16+ 1 month
|
109.7500 cells/uL
Standard Deviation 53.11230
|
|
Immunologic Assessment_Part 1
CD16+ 2 months
|
100.5000 cells/uL
Standard Deviation 47.59202
|
|
Immunologic Assessment_Part 1
CD56+ (NKT cells) Screening
|
85.4500 cells/uL
Standard Deviation 85.14507
|
|
Immunologic Assessment_Part 1
CD56+ (NKT cells) 24 hours
|
56.5000 cells/uL
Standard Deviation 61.00213
|
|
Immunologic Assessment_Part 1
CD56+ (NKT cells) 1 week
|
73.9500 cells/uL
Standard Deviation 69.58934
|
|
Immunologic Assessment_Part 1
CD19+ (B-lymphocyte antigen) 1 month
|
70.0000 cells/uL
Standard Deviation 50.51732
|
|
Immunologic Assessment_Part 1
CD19+ (B-lymphocyte antigen) 2 months
|
87.0000 cells/uL
Standard Deviation 51.71718
|
SECONDARY outcome
Timeframe: Screening, 24 hours, 1 week and 1 and 2 months post procedure.Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments: C-reactive protein \[CRP\], from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
Outcome measures
| Measure |
VORTX Rx Treatment
n=4 ablation procedures
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Immunologic Assessment_Part 2
C reactive protein Screening
|
5.9750 mg/L
Standard Deviation 5.67355
|
|
Immunologic Assessment_Part 2
C reactive protein 24 hours
|
6.0250 mg/L
Standard Deviation 7.06323
|
|
Immunologic Assessment_Part 2
C reactive protein 1 week
|
30.8250 mg/L
Standard Deviation 53.05735
|
|
Immunologic Assessment_Part 2
C reactive protein 1 month
|
4.7750 mg/L
Standard Deviation 3.57713
|
|
Immunologic Assessment_Part 2
C reactive protein 2 months
|
11.9500 mg/L
Standard Deviation 8.85795
|
SECONDARY outcome
Timeframe: Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure.Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests): complement C3 and C4, immunoglobulins \[IgG, IgM, IgA\] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
Outcome measures
| Measure |
VORTX Rx Treatment
n=4 ablation procedures
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Immunologic Assessment_Part 3
Complement C3 Screening
|
144.0000 mg/dL
Standard Deviation 53.61592
|
|
Immunologic Assessment_Part 3
Complement C3 24 hours
|
123.2000 mg/dL
Standard Deviation 25.76354
|
|
Immunologic Assessment_Part 3
Complement C3 1 week
|
150.5000 mg/dL
Standard Deviation 22.75229
|
|
Immunologic Assessment_Part 3
Complement C3 1 month
|
143.9000 mg/dL
Standard Deviation 44.60239
|
|
Immunologic Assessment_Part 3
Complement C3 2 months
|
134.7500 mg/dL
Standard Deviation 26.88711
|
|
Immunologic Assessment_Part 3
Complement C4 Screening
|
30.7750 mg/dL
Standard Deviation 20.29949
|
|
Immunologic Assessment_Part 3
Complement C4 24 hours
|
23.7750 mg/dL
Standard Deviation 6.58401
|
|
Immunologic Assessment_Part 3
Complement C4 1 week
|
29.8250 mg/dL
Standard Deviation 9.00717
|
|
Immunologic Assessment_Part 3
Complement C4 1 month
|
26.9500 mg/dL
Standard Deviation 11.01348
|
|
Immunologic Assessment_Part 3
Complement C4 2 months
|
28.0750 mg/dL
Standard Deviation 14.47236
|
|
Immunologic Assessment_Part 3
IgG Screening
|
867.2500 mg/dL
Standard Deviation 326.38359
|
|
Immunologic Assessment_Part 3
IgG 24 hours
|
792.9000 mg/dL
Standard Deviation 354.83048
|
|
Immunologic Assessment_Part 3
IgG 1 week
|
856.0000 mg/dL
Standard Deviation 335.22430
|
|
Immunologic Assessment_Part 3
IgG 1 month
|
916.7500 mg/dL
Standard Deviation 338.63784
|
|
Immunologic Assessment_Part 3
IgG 2 months
|
899.0000 mg/dL
Standard Deviation 334.19655
|
|
Immunologic Assessment_Part 3
IgM Screening
|
132.6250 mg/dL
Standard Deviation 59.75139
|
|
Immunologic Assessment_Part 3
IgM 24 hours
|
120.9000 mg/dL
Standard Deviation 51.44745
|
|
Immunologic Assessment_Part 3
IgM 1 week
|
132.3500 mg/dL
Standard Deviation 45.62846
|
|
Immunologic Assessment_Part 3
IgM 1 month
|
140.7500 mg/dL
Standard Deviation 43.69115
|
|
Immunologic Assessment_Part 3
IgM 2 months
|
141.2500 mg/dL
Standard Deviation 52.94075
|
|
Immunologic Assessment_Part 3
IgA Screening
|
147.5000 mg/dL
Standard Deviation 133.49871
|
|
Immunologic Assessment_Part 3
IgA 24 hours
|
130.0000 mg/dL
Standard Deviation 119.05766
|
|
Immunologic Assessment_Part 3
IgA 1 week
|
142.8000 mg/dL
Standard Deviation 131.15955
|
|
Immunologic Assessment_Part 3
IgA 1 month
|
145.9500 mg/dL
Standard Deviation 116.11530
|
|
Immunologic Assessment_Part 3
IgA 2 months
|
129.3750 mg/dL
Standard Deviation 84.51147
|
SECONDARY outcome
Timeframe: Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure.Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests: complement CH50, alfa-fetoprotein \[AFP\], Cancer Antigens CA15-3 \[Breast Cancer\] and CA 19-9 \[Pancreatic Cancer\]) from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
Outcome measures
| Measure |
VORTX Rx Treatment
n=4 ablation procedures
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Immunologic Assessment_Part 4
CA 19-9 (pancreatic cancer) 2 months
|
256.9525 U/ml
Standard Deviation 475.14915
|
|
Immunologic Assessment_Part 4
Complement CH50 Screening
|
72.7500 U/ml
Standard Deviation 26.87471
|
|
Immunologic Assessment_Part 4
Complement CH50 24 hours
|
61.5000 U/ml
Standard Deviation 37.59876
|
|
Immunologic Assessment_Part 4
Complement CH50 1 week
|
61.0000 U/ml
Standard Deviation 34.02940
|
|
Immunologic Assessment_Part 4
Complement CH50 1 month
|
52.2500 U/ml
Standard Deviation 24.18505
|
|
Immunologic Assessment_Part 4
Complement CH50 2 months
|
60.2500 U/ml
Standard Deviation 36.59121
|
|
Immunologic Assessment_Part 4
AFP Screening
|
544.8050 U/ml
Standard Deviation 1084.79682
|
|
Immunologic Assessment_Part 4
AFP 24 hours
|
417.8550 U/ml
Standard Deviation 831.43014
|
|
Immunologic Assessment_Part 4
AFP 1 week
|
502.2350 U/ml
Standard Deviation 999.84372
|
|
Immunologic Assessment_Part 4
AFP 1 month
|
264.1675 U/ml
Standard Deviation 523.22173
|
|
Immunologic Assessment_Part 4
AFP 2 months
|
224.5900 U/ml
Standard Deviation 441.61247
|
|
Immunologic Assessment_Part 4
CA 15-3 (breast cancer) Screening
|
15.8500 U/ml
Standard Deviation 9.02940
|
|
Immunologic Assessment_Part 4
CA 15-3 (breast cancer) 24 hours
|
14.0000 U/ml
Standard Deviation 6.66433
|
|
Immunologic Assessment_Part 4
CA 15-3 (breast cancer) 1 week
|
14.3750 U/ml
Standard Deviation 7.20804
|
|
Immunologic Assessment_Part 4
CA 15-3 (breast cancer) 1 month
|
16.2250 U/ml
Standard Deviation 9.31786
|
|
Immunologic Assessment_Part 4
CA 15-3 (breast cancer) 2months
|
15.4250 U/ml
Standard Deviation 7.08396
|
|
Immunologic Assessment_Part 4
CA 19-9 (pancreatic cancer) Screening
|
167.8175 U/ml
Standard Deviation 300.24702
|
|
Immunologic Assessment_Part 4
CA 19-9 (pancreatic cancer) 24 hours
|
174.8450 U/ml
Standard Deviation 312.86710
|
|
Immunologic Assessment_Part 4
CA 19-9 (pancreatic cancer) 1 week
|
169.1675 U/ml
Standard Deviation 290.56204
|
|
Immunologic Assessment_Part 4
CA 19-9 (pancreatic cancer) 1 month
|
168.1200 U/ml
Standard Deviation 285.77017
|
SECONDARY outcome
Timeframe: Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure.Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests): interleukin-6 \[IL-6\] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
Outcome measures
| Measure |
VORTX Rx Treatment
n=4 ablation procedures
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Immunologic Assessment_Part 5
Interleukin-6 Screening
|
4.2225 pg/dl
Standard Deviation 2.88648
|
|
Immunologic Assessment_Part 5
Interleukin-6 24 hours
|
3.4575 pg/dl
Standard Deviation 1.97481
|
|
Immunologic Assessment_Part 5
Interleukin-6 1 week
|
14.7850 pg/dl
Standard Deviation 14.05719
|
|
Immunologic Assessment_Part 5
Interleukin-6 1 month
|
3.8750 pg/dl
Standard Deviation 2.37905
|
|
Immunologic Assessment_Part 5
Interleukin-6 2 months
|
5.8125 pg/dl
Standard Deviation 2.84372
|
SECONDARY outcome
Timeframe: Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure.Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests): carcinoembryonic antigen \[CEA\] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
Outcome measures
| Measure |
VORTX Rx Treatment
n=4 ablation procedures
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Immunologic Assessment_Part 6
CEA Screening
|
46.9300 ng/ml
Standard Deviation 50.75086
|
|
Immunologic Assessment_Part 6
CEA 24 hours
|
50.4200 ng/ml
Standard Deviation 55.16530
|
|
Immunologic Assessment_Part 6
CEA 1 week
|
37.7925 ng/ml
Standard Deviation 45.10227
|
|
Immunologic Assessment_Part 6
CEA 1 month
|
44.6150 ng/ml
Standard Deviation 64.11322
|
|
Immunologic Assessment_Part 6
CEA 2 months
|
54.0225 ng/ml
Standard Deviation 97.45371
|
SECONDARY outcome
Timeframe: Screening, 1 and 2 months post procedure.The EORTC QLQ-C30 is a 30-item generic health-related QoL instrument designed to assess cancer patients' physical, psychological and social functioning. It is composed of 9 multi-item scales (5 functional scales \[physical, role, cognitive, emotional, and social\], a global QoL scale \[GQoL\], and 3 symptom scales \[fatigue, pain, and nausea and vomiting\]), 5 single-item symptom scales assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea), and an item on the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0-100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. However, a high score for a symptom scale/item represents a high level of symptomatology/problems.
Outcome measures
| Measure |
VORTX Rx Treatment
n=4 ablation procedures
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Role functioning screening
|
87.5000 score on a scale
Standard Deviation 15.95712
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Global health status/QoL Screening
|
70.8333 score on a scale
Standard Deviation 15.95712
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Global health status/QoL 1 month
|
58.3333 score on a scale
Standard Deviation 28.05418
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Global health status/QoL 2 months
|
70.8333 score on a scale
Standard Deviation 25.00000
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Physical functioning Screening
|
81.6667 score on a scale
Standard Deviation 12.61980
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Physical functioning 1 month
|
83.3333 score on a scale
Standard Deviation 13.87777
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Physical functioning 2 months
|
81.6667 score on a scale
Standard Deviation 18.35857
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Role functioning 1 month
|
70.8333 score on a scale
Standard Deviation 28.46375
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Role functioning 2 months
|
83.3333 score on a scale
Standard Deviation 13.60828
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Emotional functioning Screening
|
87.5000 score on a scale
Standard Deviation 8.33333
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Emotional functioning 1 month
|
87.5000 score on a scale
Standard Deviation 19.83730
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Emotional functioning 2 months
|
83.3333 score on a scale
Standard Deviation 18.00206
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Cognitive functioning Screening
|
79.1667 score on a scale
Standard Deviation 20.97176
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Cognitive functioning 1 month
|
75.0000 score on a scale
Standard Deviation 21.51657
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Cognitive functioning 2 months
|
79.1667 score on a scale
Standard Deviation 31.54949
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Social functioning Screening
|
95.8333 score on a scale
Standard Deviation 8.33333
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Social functioning 1 month
|
83.3333 score on a scale
Standard Deviation 13.60828
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Social functioning 2 months
|
95.8333 score on a scale
Standard Deviation 8.33333
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Fatigue Screening
|
30.5556 score on a scale
Standard Deviation 13.98117
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Fatigue 1 month
|
41.6667 score on a scale
Standard Deviation 27.77778
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Fatigue 2 months
|
25.0000 score on a scale
Standard Deviation 24.63729
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Nausea and vomiting Screening
|
0 score on a scale
Standard Deviation 0
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Nausea and vomiting 1 month
|
0 score on a scale
Standard Deviation 0
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Nausea and vomiting 1 months
|
0 score on a scale
Standard Deviation 0
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Pain Screening
|
16.6667 score on a scale
Standard Deviation 23.57023
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Pain 1 month
|
20.8333 score on a scale
Standard Deviation 31.54949
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Pain 2 months
|
41.6667 score on a scale
Standard Deviation 34.69443
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Dyspnea Screening
|
0 score on a scale
Standard Deviation 0
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Dyspnea 1 month
|
0 score on a scale
Standard Deviation 0
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Dyspnea 2 months
|
0 score on a scale
Standard Deviation 0
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Insomnia Screening
|
41.6667 score on a scale
Standard Deviation 41.94352
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Insomnia 1 month
|
33.3333 score on a scale
Standard Deviation 47.14045
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Insomnia 2 months
|
25.0000 score on a scale
Standard Deviation 31.91424
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Appetite loss Screening
|
25.0000 score on a scale
Standard Deviation 50.00000
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Appetite loss 1 month
|
50.0000 score on a scale
Standard Deviation 43.03315
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Appetite loss 2 months
|
8.3333 score on a scale
Standard Deviation 16.66667
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Constipation Screening
|
8.3333 score on a scale
Standard Deviation 16.66667
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Constipation 1 month
|
0 score on a scale
Standard Deviation 0
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Constipation 2 months
|
0 score on a scale
Standard Deviation 0
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Diarrhea Screening
|
33.3333 score on a scale
Standard Deviation 47.14045
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Diarrhea 1 month
|
16.6667 score on a scale
Standard Deviation 19.24501
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Diarrhea 2 months
|
16.6667 score on a scale
Standard Deviation 19.24501
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Financial difficulties Screening
|
16.6667 score on a scale
Standard Deviation 19.24501
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Financial difficulties 1 month
|
8.3333 score on a scale
Standard Deviation 16.66667
|
|
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
Financial difficulties 2 months
|
8.3333 score on a scale
Standard Deviation 16.66667
|
SECONDARY outcome
Timeframe: 1-day post ablation and 1 week post procedure.Perform pain assessment by a 100 mm visual analog scale (VAS) where 0 is "no pain" and 100 is "the maximum pain possible" at 1-day and 1-week post-procedure.
Outcome measures
| Measure |
VORTX Rx Treatment
n=7 ablation procedures
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Pain Assessment by VAS Scale
VAS score: 24 hours
|
4.3 score on a scale
Standard Deviation 7.9
|
|
Pain Assessment by VAS Scale
VAS score: 1 week
|
25.0 score on a scale
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: in the 24-hour period post-procedure and during the one week period post-procedurePopulation: Number of patients with at least one drug due to Post-procedure pain (concomitant medication form).
Evaluate analgesic treatment prescription in the 24-hour period post-procedure and during the one week period post-procedure.
Outcome measures
| Measure |
VORTX Rx Treatment
n=8 Participants
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Analgesic Requirements After the Ablation Procedure
At least one drug due to post-procedure pain: YES
|
5 Participants
|
|
Analgesic Requirements After the Ablation Procedure
At least one drug due to post-procedure pain: NO
|
3 Participants
|
Adverse Events
VORTX Rx Treatment
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VORTX Rx Treatment
n=8 participants at risk
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
General disorders
FEVER
|
12.5%
1/8 • Number of events 1 • 2 months
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
12.5%
1/8 • Number of events 1 • 2 months
|
Other adverse events
| Measure |
VORTX Rx Treatment
n=8 participants at risk
Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound
|
|---|---|
|
Hepatobiliary disorders
Transaminase elevation
|
12.5%
1/8 • 2 months
|
|
General disorders
Abdominal discomfort
|
12.5%
1/8 • 2 months
|
|
General disorders
Abdominal pain
|
12.5%
1/8 • 2 months
|
|
Nervous system disorders
Adverse reaction to analeptics and opioid receptor antagonists
|
12.5%
1/8 • 2 months
|
|
Hepatobiliary disorders
Alkaline phosphatase increase
|
12.5%
1/8 • 2 months
|
|
Hepatobiliary disorders
ALT increase
|
50.0%
4/8 • 2 months
|
|
Metabolism and nutrition disorders
Anemia
|
12.5%
1/8 • 2 months
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
2/8 • 2 months
|
|
Metabolism and nutrition disorders
Appetite increase
|
12.5%
1/8 • 2 months
|
|
Hepatobiliary disorders
Ascites
|
12.5%
1/8 • 2 months
|
|
Hepatobiliary disorders
AST increase
|
50.0%
4/8 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Chest punctures
|
12.5%
1/8 • 2 months
|
|
Renal and urinary disorders
Choluria
|
12.5%
1/8 • 2 months
|
|
Musculoskeletal and connective tissue disorders
Coccyx pain
|
12.5%
1/8 • 2 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • 2 months
|
|
Skin and subcutaneous tissue disorders
Desquamative lesions
|
12.5%
1/8 • 2 months
|
|
General disorders
Fatigue
|
50.0%
4/8 • 2 months
|
|
General disorders
Fever
|
12.5%
1/8 • 2 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
12.5%
1/8 • 2 months
|
|
General disorders
General pain
|
12.5%
1/8 • 2 months
|
|
Hepatobiliary disorders
GGT increase
|
25.0%
2/8 • 2 months
|
|
Skin and subcutaneous tissue disorders
Itchy skin
|
12.5%
1/8 • 2 months
|
|
Hepatobiliary disorders
Jaundice
|
12.5%
1/8 • 2 months
|
|
Musculoskeletal and connective tissue disorders
Left leg pain
|
12.5%
1/8 • 2 months
|
|
Nervous system disorders
Lipotomy
|
12.5%
1/8 • 2 months
|
|
Musculoskeletal and connective tissue disorders
Malleolar edema with fovea
|
12.5%
1/8 • 2 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • 2 months
|
|
General disorders
Occasional fever
|
12.5%
1/8 • 2 months
|
|
Musculoskeletal and connective tissue disorders
Pain in right shoulder
|
12.5%
1/8 • 2 months
|
|
Musculoskeletal and connective tissue disorders
Pain in right side
|
12.5%
1/8 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Right basal pneumonia
|
12.5%
1/8 • 2 months
|
|
Nervous system disorders
Sciatic pain
|
37.5%
3/8 • 2 months
|
|
Vascular disorders
Swollen ankles
|
12.5%
1/8 • 2 months
|
|
Nervous system disorders
Tingling in feet and hands
|
12.5%
1/8 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results or conclusions of this study will be reported at scientific congresses and published in scientific journals. The investigator agrees to maintain this information in strict confidence, and will not use it for any other purpose without the written authorization of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER