Trial Outcomes & Findings for Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization (NCT NCT02471313)

Last Updated: 2019-04-23

Results Overview

A single dose of study imaging agent \[18F\] FMISO was administered following the TACE procedure. PET Scan imaging was then performed to evaluate if hypoxic tumor identification were observable following administration of study imaging agent. Power and significance calculations are not applicable to this small sample feasibility study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

up to 72 hours after injection of [18F] FMISO

Results posted on

2019-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	[18F] FMISO PET Scan Patients with primary hepatic malignancy who underwent \[18F\] FMISO PET Scan following transarterial chemoembolization (TACE) procedure \[18F\] FMISO: \[18F\] Fluromisonidazole, 1 h-(3-\[18F\]-fluro-2hydroxyl-propy10-2-nitro-imidazaole is an investigational positron emission tomography (PET) radiopharmaceutical for injection and used to visualize hypoxia imaging agent. Each patient will receive up to 10 mCi of \[18F\] FMISO PET imaging post TACE procedure.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	[18F] FMISO PET Scan n=3 Participants Patients with primary hepatic malignancy who underwent \[18F\] FMISO PET Scan following transarterial chemoembolization (TACE) procedure \[18F\] FMISO: \[18F\] Fluromisonidazole, 1 h-(3-\[18F\]-fluro-2hydroxyl-propy10-2-nitro-imidazaole is an investigational positron emission tomography (PET) radiopharmaceutical for injection and used to visualize hypoxia imaging agent. Each patient will receive up to 10 mCi of \[18F\] FMISO PET imaging post TACE procedure.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants
Transarterial Chemoembolization procedure	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 72 hours after injection of [18F] FMISO

Outcome measures

Outcome measures
Measure	Uptake of [18F] FMISO With PET Scan Imaging n=3 Participants Patients with primary hepatic malignancy who underwent \[18F\] FMISO PET Scan following transarterial chemoembolization (TACE) procedure \[18F\] FMISO: \[18F\] Fluromisonidazole, 1 h-(3-\[18F\]-fluro-2hydroxyl-propy10-2-nitro-imidazaole is an investigational positron emission tomography (PET) radiopharmaceutical for injection and used to visualize hypoxia imaging agent. Each patient will receive up to 10 mCi of \[18F\] FMISO PET imaging post TACE procedure.
Number of Participants for Which Uptake of [18F]-FMISO Was Successful and Hypoxic Tumors Were Observed During PET Scan Imaging Post TACE Procedure	0 Participants

Adverse Events

[18F] FMISO PET Scan

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	[18F] FMISO PET Scan n=3 participants at risk Patients with primary hepatic malignancy are undergo \[18F\] FMISO PET Scan following transarterial chemoembolization (TACE) procedure.
Musculoskeletal and connective tissue disorders Generalized weakness	33.3% 1/3 • Number of events 1 • Adverse event data were collected within 24 hours post [18F] FMISO injection on all study participants

Additional Information

Dr. Elliot Levy, Staff Clinician, Radiology & Imaging Sciences

National Institutes of Health Clinical Center

Phone: 301-402-5368

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place