Trial Outcomes & Findings for A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping (NCT NCT02209532)
NCT ID: NCT02209532
Last Updated: 2019-03-25
Results Overview
To assess the effectiveness of intraoperative PINPOINT Near Infrared Fluorescence Imaging in the identification of lymph nodes in subjects with uterine and cervical malignancies who are undergoing lymph node mapping.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
Day 0
Results posted on
2019-03-25
Participant Flow
Participant milestones
| Measure |
Lymph Node Mapping With Isosulfan Blue Followed by PINPOINT
The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
Lymph Node Mapping With PINPOINT Followed by Isosulfan Blue
The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
COMPLETED
|
87
|
89
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping
Baseline characteristics by cohort
| Measure |
Blue - PINPOINT
n=87 Participants
The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
PINPOINT - Blue
n=89 Participants
The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
30-39
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Customized
40-49
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Customized
50-59
|
20 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Age, Customized
60-69
|
33 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Age, Customized
70-79
|
20 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Age, Customized
>80
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
87 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
176 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
66 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Smoking Status
Never
|
66 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
131 Participants
n=206 Participants
|
|
Smoking Status
Current
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Smoking Status
Past
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Alcohol Consumption
Yes
|
34 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Alcohol Consumption
No
|
53 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
ASA Classification
I - A normal healthy patient
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
ASA Classification
II - A patient with mild systemic disease
|
38 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
ASA Classification
III - A patient with severe systemic disease
|
34 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
ASA Classification
Unknown ASA Classification
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Preoperative Diagnosis
Stage 1 Endometrial Cancer
|
84 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Preoperative Diagnosis
Stage 1 Cervical Cancer
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Preoperative Diagnosis
Stage 1A Cervical Cancer
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Endometrial Cancer Histology
Adenocarcinoma
|
71 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
|
Endometrial Cancer Histology
Serous Carcinoma
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Endometrial Cancer Histology
Clear Cell Carcinoma
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Endometrial Cancer Histology
Carcinosarcoma
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Endometrial Cancer Histology
Other
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Cervical Cancer Histology
Squamous Cell Carcinoma
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Cervical Cancer Histology
Adenocarcinoma
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: All analyses were completed using the number of lymph nodes identified.
To assess the effectiveness of intraoperative PINPOINT Near Infrared Fluorescence Imaging in the identification of lymph nodes in subjects with uterine and cervical malignancies who are undergoing lymph node mapping.
Outcome measures
| Measure |
PINPOINT - Blue
n=238 Confirmed Lymph Nodes
The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
Blue - PINPOINT
n=247 Confirmed Lymph Nodes
The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
|---|---|---|
|
Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified
|
232 Confirmed Lymph Nodes
|
239 Confirmed Lymph Nodes
|
SECONDARY outcome
Timeframe: Day 0Population: 180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).
To evaluate the effectiveness of PINPOINT and Blue dye in the identification of at least one lymph node (confirmed to be lymphoid tissue) per subject.
Outcome measures
| Measure |
PINPOINT - Blue
n=82 Participants
The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
Blue - PINPOINT
n=81 Participants
The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
|---|---|---|
|
Effectiveness of PINPOINT and Blue Dye in the Identification of at Least One Lymph Node Defined as the Number of Subjects in Which at Least One Confirmed Lymph Node Was Identified With Either PINPOINT or Blue Dye
IC2000 and PINPOINT
|
80 Number of Subjects
|
79 Number of Subjects
|
|
Effectiveness of PINPOINT and Blue Dye in the Identification of at Least One Lymph Node Defined as the Number of Subjects in Which at Least One Confirmed Lymph Node Was Identified With Either PINPOINT or Blue Dye
Isosulfan Blue
|
64 Number of Subjects
|
60 Number of Subjects
|
SECONDARY outcome
Timeframe: Day 0Population: 180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).
To evaluate the effectiveness of PINPOINT and Blue dye in the identification of bilateral lymph nodes (confirmed to be lymphoid tissue).
Outcome measures
| Measure |
PINPOINT - Blue
n=82 Participants
The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
Blue - PINPOINT
n=81 Participants
The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
|---|---|---|
|
Effectiveness of PINPOINT and Blue Dye in the Identification of Bilateral Lymph Nodes Defined as the Number of Subjects in Which Lymph Nodes Were Identified Bilaterally With Either PINPOINT or Blue Dye.
IC2000 and PINPOINT
|
64 Number of Subjects
|
60 Number of Subjects
|
|
Effectiveness of PINPOINT and Blue Dye in the Identification of Bilateral Lymph Nodes Defined as the Number of Subjects in Which Lymph Nodes Were Identified Bilaterally With Either PINPOINT or Blue Dye.
Isosulfan Blue
|
24 Number of Subjects
|
25 Number of Subjects
|
SECONDARY outcome
Timeframe: Day 0Population: 180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).
To determine the proportion of lymph nodes identified from following lymphatic channels
Outcome measures
| Measure |
PINPOINT - Blue
n=82 Participants
The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
Blue - PINPOINT
n=81 Participants
The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
|---|---|---|
|
Identification of Lymph Nodes Following Lymphatic Channels Defined as the Number of Subjects in Which Confirmed Lymph Nodes Were Identified by Following a Lymphatic Channel With Either PINPOINT or Blue Dye.
IC2000 and PINPOINT
|
6 Number of Subjects
|
3 Number of Subjects
|
|
Identification of Lymph Nodes Following Lymphatic Channels Defined as the Number of Subjects in Which Confirmed Lymph Nodes Were Identified by Following a Lymphatic Channel With Either PINPOINT or Blue Dye.
Isosulfan Blue
|
8 Number of Subjects
|
6 Number of Subjects
|
SECONDARY outcome
Timeframe: Day 0 to Day 30Population: 180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).
To assess the safety of interstitial injection of ICG for intraoperative lymphatic mapping, as measured by number of subjects experiencing adverse effects related to the study treatment.
Outcome measures
| Measure |
PINPOINT - Blue
n=89 Participants
The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
Blue - PINPOINT
n=87 Participants
The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
|---|---|---|
|
Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG
|
0 Number of subjects
|
0 Number of subjects
|
SECONDARY outcome
Timeframe: Day 0Population: 180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).
To determine the anatomic distribution of lymph nodes
Outcome measures
| Measure |
PINPOINT - Blue
n=232 Lymph Nodes
The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
Blue - PINPOINT
n=239 Lymph Nodes
The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
|---|---|---|
|
Anatomic Distribution of Lymph Nodes
Left obturator/internal iliac
|
28 confirmed lymph nodes
|
36 confirmed lymph nodes
|
|
Anatomic Distribution of Lymph Nodes
Left external iliac
|
69 confirmed lymph nodes
|
67 confirmed lymph nodes
|
|
Anatomic Distribution of Lymph Nodes
Left common iliac
|
11 confirmed lymph nodes
|
6 confirmed lymph nodes
|
|
Anatomic Distribution of Lymph Nodes
Right obturator/internal iliac
|
39 confirmed lymph nodes
|
45 confirmed lymph nodes
|
|
Anatomic Distribution of Lymph Nodes
Right external iliac
|
52 confirmed lymph nodes
|
50 confirmed lymph nodes
|
|
Anatomic Distribution of Lymph Nodes
Right common iliac
|
17 confirmed lymph nodes
|
18 confirmed lymph nodes
|
|
Anatomic Distribution of Lymph Nodes
Presacral
|
2 confirmed lymph nodes
|
5 confirmed lymph nodes
|
|
Anatomic Distribution of Lymph Nodes
Para-aortic node below IMA
|
4 confirmed lymph nodes
|
5 confirmed lymph nodes
|
|
Anatomic Distribution of Lymph Nodes
Other
|
10 confirmed lymph nodes
|
7 confirmed lymph nodes
|
Adverse Events
Blue - PINPOINT
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
PINPOINT - Blue
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Blue - PINPOINT
n=87 participants at risk
The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
PINPOINT - Blue
n=89 participants at risk
The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
|---|---|---|
|
Gastrointestinal disorders
Partial bowel obstruction
|
1.1%
1/87 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
0.00%
0/89 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.1%
1/87 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
0.00%
0/89 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Trace pleural effusions
|
1.1%
1/87 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
0.00%
0/89 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/87 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
0.00%
0/89 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/87 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
1.1%
1/89 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
Other adverse events
| Measure |
Blue - PINPOINT
n=87 participants at risk
The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
PINPOINT - Blue
n=89 participants at risk
The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.
PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural Pain
|
14.9%
13/87 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
11.2%
10/89 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
7/87 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
4.5%
4/89 • 30 Days
Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place