Trial Outcomes & Findings for Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging (NCT NCT03303469)

Results Overview

Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

At baseline

Results posted on

2021-02-21

Participant Flow

Participant milestones

Participant milestones
Measure	FMISO PET Imaging Post TACE and SBRT FMISO imaging at baseline, post-TACE and post-SBRT FMISO: FMISO PET/CT imaging at baseline FMISO: FMISO PET/CT post TACE FMISO: FMISO PET/CT post SBRT
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	FMISO PET Imaging Post TACE and SBRT FMISO imaging at baseline, post-TACE and post-SBRT FMISO: FMISO PET/CT imaging at baseline FMISO: FMISO PET/CT post TACE FMISO: FMISO PET/CT post SBRT
Overall Study Lost to Follow-up	2

Baseline Characteristics

Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FMISO PET Imaging Post TACE and SBRT n=3 Participants FMISO imaging at baseline, post-TACE and post-SBRT FMISO: FMISO PET/CT imaging at baseline FMISO: FMISO PET/CT post TACE FMISO: FMISO PET/CT post SBRT
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline

Population: We were unable to perform the statistical analysis due to insufficient data collection.

Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 month post-TACE procedures and prior to SBRT

Population: We were unable to perform the statistical analysis due to insufficient data collection.

Perform PET/CT imaging using FMISO post-TACE and prior to Stereotactic body radiation therapy (SBRT) to determine tumor hypoxia

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 month post-SBRT

Population: We were unable to perform the statistical analysis due to insufficient data collection.

Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia

Outcome measures

Outcome data not reported

Adverse Events

FMISO PET Imaging Post TACE and SBRT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Janis O'Malley

The University of Alabama at Birmingham

Phone: 205-934-6504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place