Trial Outcomes & Findings for LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors (NCT NCT02649868)
NCT ID: NCT02649868
Last Updated: 2024-07-11
Results Overview
Perfusion on x-ray was assessed after delivery of transarterial embolization beads. Qualitative geometric analysis of actual and virtual perfusion was performed with data available using custom software analysis after selective injections of image-able beads during transcatheter intra-arterial delivery to the liver. Liver boundary and super selective perfused boundary were segmented and compared for distribution of beads on virtual and actual perfusion for possible match. Analysis was the visibility of beads upon transcatheter intra-arterial delivery to the liver and evaluation of impact on perfusion from subjective evaluation during procedural angiography, and/or cone beam CT. Qualitative analysis was done to determine match for distribution of beads on virtual and actual perfusion.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Intra-procedure
Results posted on
2024-07-11
Participant Flow
Of the 19 participants who were consented, two participants were unevaluable so were excluded from the study
Participant milestones
| Measure |
Hepatic Tumors Bead Embolization
Participants with diagnosed hepatic malignancy underwent transarterial embolization (TAE) with or without thermal ablation under general anesthesia. The LC LUMI bead were used in the transarterial embolization procedure.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors
Baseline characteristics by cohort
| Measure |
Hepatic Tumors Bead Embolization
n=17 Participants
Participants with diagnosed hepatic malignancy underwent transarterial embolization (TAE) with or without thermal ablation under general anesthesia. The LC LUMI bead were used in the transarterial embolization procedure.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Intra-procedurePopulation: Participants who completed the transcatheter intra-arterial (TAE) procedure
Perfusion on x-ray was assessed after delivery of transarterial embolization beads. Qualitative geometric analysis of actual and virtual perfusion was performed with data available using custom software analysis after selective injections of image-able beads during transcatheter intra-arterial delivery to the liver. Liver boundary and super selective perfused boundary were segmented and compared for distribution of beads on virtual and actual perfusion for possible match. Analysis was the visibility of beads upon transcatheter intra-arterial delivery to the liver and evaluation of impact on perfusion from subjective evaluation during procedural angiography, and/or cone beam CT. Qualitative analysis was done to determine match for distribution of beads on virtual and actual perfusion.
Outcome measures
| Measure |
Hepatic Tumors Bead Embolization
n=17 Participants
Participants with diagnosed hepatic malignancy underwent transarterial embolization (TAE) with or without thermal ablation under general anesthesia. The LC LUMI bead were used in the transarterial embolization procedure.
|
|---|---|
|
Perfusion Characteristics of Imageable Beads Using Cone Beam CT
Yes
|
17 Participants
|
|
Perfusion Characteristics of Imageable Beads Using Cone Beam CT
No
|
0 Participants
|
PRIMARY outcome
Timeframe: One year post procedurePopulation: Participants who completed the transcatheter intra-arterial (TAE) procedure and had one year follow up visit
Perfusion on x-ray was assessed after delivery of transarterial embolization beads. Qualitative geometric analysis of actual and virtual perfusion was performed with data available using custom software analysis after selective injections of image-able beads during transcatheter intra-arterial delivery to the liver. Liver boundary and super selective perfused boundary were segmented and compared for distribution of beads on virtual and actual perfusion for possible match. Analysis was the visibility of beads upon transcatheter intra-arterial delivery to the liver and evaluation of impact on perfusion from subjective evaluation during procedural angiography, and/or cone beam CT. Qualitative analysis was done to determine match for distribution of beads on virtual and actual perfusion
Outcome measures
| Measure |
Hepatic Tumors Bead Embolization
n=12 Participants
Participants with diagnosed hepatic malignancy underwent transarterial embolization (TAE) with or without thermal ablation under general anesthesia. The LC LUMI bead were used in the transarterial embolization procedure.
|
|---|---|
|
Perfusion Characteristics of Imageable Beads Using Cone Beam CT
Yes
|
12 Participants
|
|
Perfusion Characteristics of Imageable Beads Using Cone Beam CT
No
|
0 Participants
|
Adverse Events
Hepatic Tumors Bead Embolization
Serious events: 6 serious events
Other events: 17 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Hepatic Tumors Bead Embolization
n=17 participants at risk
Participants with diagnosed hepatic malignancy underwent transarterial embolization (TAE) with or without thermal ablation under general anesthesia. The LC LUMI bead were used in the transarterial embolization procedure.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.9%
1/17 • Up to one year post procedure
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
1/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
2/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Diarrhea
|
11.8%
2/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Retroperitoneal Hemorrhage
|
5.9%
1/17 • Up to one year post procedure
|
|
General disorders
Death
|
11.8%
2/17 • Up to one year post procedure
|
|
General disorders
Edema peripheral
|
5.9%
1/17 • Up to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.9%
1/17 • Up to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
5.9%
1/17 • Up to one year post procedure
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • Up to one year post procedure
|
|
Vascular disorders
Subdural haematoma
|
5.9%
1/17 • Up to one year post procedure
|
Other adverse events
| Measure |
Hepatic Tumors Bead Embolization
n=17 participants at risk
Participants with diagnosed hepatic malignancy underwent transarterial embolization (TAE) with or without thermal ablation under general anesthesia. The LC LUMI bead were used in the transarterial embolization procedure.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
88.2%
15/17 • Up to one year post procedure
|
|
Blood and lymphatic system disorders
Lymphopenia
|
82.4%
14/17 • Up to one year post procedure
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.5%
4/17 • Up to one year post procedure
|
|
Cardiac disorders
Chest pain
|
11.8%
2/17 • Up to one year post procedure
|
|
Cardiac disorders
Palpitations
|
11.8%
2/17 • Up to one year post procedure
|
|
Cardiac disorders
Sinus tachycardia
|
5.9%
1/17 • Up to one year post procedure
|
|
Cardiac disorders
Syncope
|
5.9%
1/17 • Up to one year post procedure
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
5.9%
1/17 • Up to one year post procedure
|
|
Endocrine disorders
Hypothyroidism
|
17.6%
3/17 • Up to one year post procedure
|
|
Eye disorders
Cataract
|
5.9%
1/17 • Up to one year post procedure
|
|
Eye disorders
Diplopia
|
5.9%
1/17 • Up to one year post procedure
|
|
Eye disorders
Eye irritation
|
5.9%
1/17 • Up to one year post procedure
|
|
Eye disorders
Eyelid ptosis
|
5.9%
1/17 • Up to one year post procedure
|
|
Eye disorders
Vision blurred
|
11.8%
2/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Abdominal hernia
|
5.9%
1/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Abdominal pain
|
47.1%
8/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Abdominal pain lower
|
11.8%
2/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Abdominal pain upper
|
52.9%
9/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Constipation
|
58.8%
10/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Diarrhea
|
35.3%
6/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
1/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
1/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Gastroparesis postoperative
|
5.9%
1/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Nausea
|
52.9%
9/17 • Up to one year post procedure
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
5/17 • Up to one year post procedure
|
|
General disorders
Administration site lymphadenopathy
|
5.9%
1/17 • Up to one year post procedure
|
|
General disorders
Asthenia
|
5.9%
1/17 • Up to one year post procedure
|
|
General disorders
Axillary pain
|
5.9%
1/17 • Up to one year post procedure
|
|
General disorders
Chills
|
11.8%
2/17 • Up to one year post procedure
|
|
General disorders
Edema peripheral
|
23.5%
4/17 • Up to one year post procedure
|
|
General disorders
Face edema
|
5.9%
1/17 • Up to one year post procedure
|
|
General disorders
Facial pain
|
5.9%
1/17 • Up to one year post procedure
|
|
General disorders
Fatigue
|
41.2%
7/17 • Up to one year post procedure
|
|
General disorders
Flank pain
|
17.6%
3/17 • Up to one year post procedure
|
|
General disorders
Flushing
|
11.8%
2/17 • Up to one year post procedure
|
|
General disorders
Hyperthermia
|
70.6%
12/17 • Up to one year post procedure
|
|
General disorders
Hypothermia
|
5.9%
1/17 • Up to one year post procedure
|
|
General disorders
Injection site erythema
|
5.9%
1/17 • Up to one year post procedure
|
|
General disorders
Injection site pruritus
|
5.9%
1/17 • Up to one year post procedure
|
|
General disorders
Injection site reaction
|
5.9%
1/17 • Up to one year post procedure
|
|
General disorders
Malaise
|
5.9%
1/17 • Up to one year post procedure
|
|
General disorders
Night sweats
|
5.9%
1/17 • Up to one year post procedure
|
|
General disorders
Pain
|
52.9%
9/17 • Up to one year post procedure
|
|
General disorders
Pelvic mass
|
5.9%
1/17 • Up to one year post procedure
|
|
Hepatobiliary disorders
Biloma
|
5.9%
1/17 • Up to one year post procedure
|
|
Injury, poisoning and procedural complications
Medical device site bruise
|
5.9%
1/17 • Up to one year post procedure
|
|
Investigations
Absolute neutrophil count decreased
|
5.9%
1/17 • Up to one year post procedure
|
|
Investigations
Activated partial thromboplastin time prolonged
|
17.6%
3/17 • Up to one year post procedure
|
|
Investigations
Alanine aminotransferase increased
|
41.2%
7/17 • Up to one year post procedure
|
|
Investigations
Amylase increased
|
11.8%
2/17 • Up to one year post procedure
|
|
Investigations
Aspartate aminotransferase increased
|
64.7%
11/17 • Up to one year post procedure
|
|
Investigations
Blood alkaline phosphatase increased
|
64.7%
11/17 • Up to one year post procedure
|
|
Investigations
Blood bilirubin increased
|
11.8%
2/17 • Up to one year post procedure
|
|
Investigations
Blood creatinine increased
|
23.5%
4/17 • Up to one year post procedure
|
|
Investigations
Blood lactate dehydrogenase
|
5.9%
1/17 • Up to one year post procedure
|
|
Investigations
International normalized ratio increased
|
5.9%
1/17 • Up to one year post procedure
|
|
Investigations
Platelet count decreased
|
29.4%
5/17 • Up to one year post procedure
|
|
Investigations
Weight decreased
|
5.9%
1/17 • Up to one year post procedure
|
|
Investigations
Weight increased
|
11.8%
2/17 • Up to one year post procedure
|
|
Metabolism and nutrition disorders
Anorexia nervosa
|
11.8%
2/17 • Up to one year post procedure
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.9%
1/17 • Up to one year post procedure
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.9%
1/17 • Up to one year post procedure
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.9%
1/17 • Up to one year post procedure
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.9%
1/17 • Up to one year post procedure
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
5.9%
1/17 • Up to one year post procedure
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.9%
1/17 • Up to one year post procedure
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.5%
4/17 • Up to one year post procedure
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
58.8%
10/17 • Up to one year post procedure
|
|
Metabolism and nutrition disorders
Hypokalemia
|
41.2%
7/17 • Up to one year post procedure
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
29.4%
5/17 • Up to one year post procedure
|
|
Metabolism and nutrition disorders
Hyponatremia
|
47.1%
8/17 • Up to one year post procedure
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
23.5%
4/17 • Up to one year post procedure
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
41.2%
7/17 • Up to one year post procedure
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
17.6%
3/17 • Up to one year post procedure
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.8%
2/17 • Up to one year post procedure
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
17.6%
3/17 • Up to one year post procedure
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
23.5%
4/17 • Up to one year post procedure
|
|
Nervous system disorders
Confusional state
|
5.9%
1/17 • Up to one year post procedure
|
|
Nervous system disorders
Dizziness
|
29.4%
5/17 • Up to one year post procedure
|
|
Nervous system disorders
Headache
|
52.9%
9/17 • Up to one year post procedure
|
|
Nervous system disorders
Insomnia
|
11.8%
2/17 • Up to one year post procedure
|
|
Nervous system disorders
Neuropathy peripheral
|
5.9%
1/17 • Up to one year post procedure
|
|
Nervous system disorders
Paresthesia
|
17.6%
3/17 • Up to one year post procedure
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.8%
2/17 • Up to one year post procedure
|
|
Psychiatric disorders
Anxiety
|
29.4%
5/17 • Up to one year post procedure
|
|
Psychiatric disorders
Depression
|
23.5%
4/17 • Up to one year post procedure
|
|
Renal and urinary disorders
Micturition urgency
|
5.9%
1/17 • Up to one year post procedure
|
|
Renal and urinary disorders
Nocturia
|
5.9%
1/17 • Up to one year post procedure
|
|
Renal and urinary disorders
Pollakiuria
|
5.9%
1/17 • Up to one year post procedure
|
|
Renal and urinary disorders
Proteinuria
|
17.6%
3/17 • Up to one year post procedure
|
|
Renal and urinary disorders
Urinary tract infection
|
5.9%
1/17 • Up to one year post procedure
|
|
Reproductive system and breast disorders
Breast pain
|
5.9%
1/17 • Up to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.9%
1/17 • Up to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
3/17 • Up to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.6%
3/17 • Up to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
11.8%
2/17 • Up to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Paralysis recurrent laryngeal nerve
|
5.9%
1/17 • Up to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • Up to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.9%
1/17 • Up to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
17.6%
3/17 • Up to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.9%
1/17 • Up to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea syndrome
|
5.9%
1/17 • Up to one year post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
17.6%
3/17 • Up to one year post procedure
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Up to one year post procedure
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.5%
4/17 • Up to one year post procedure
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Up to one year post procedure
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17 • Up to one year post procedure
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.9%
1/17 • Up to one year post procedure
|
|
Skin and subcutaneous tissue disorders
Skin papilloma
|
5.9%
1/17 • Up to one year post procedure
|
|
Vascular disorders
Hypertension
|
41.2%
7/17 • Up to one year post procedure
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Up to one year post procedure
|
|
Vascular disorders
Portal vein thrombosis
|
5.9%
1/17 • Up to one year post procedure
|
|
Vascular disorders
Procedural haemorrhage
|
5.9%
1/17 • Up to one year post procedure
|
|
Vascular disorders
Subclavian vein thrombosis
|
5.9%
1/17 • Up to one year post procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place