Trial Outcomes & Findings for 11C-acetate for Treatment Response After Radiotherapy for HCC (NCT NCT02549755)

Results Overview

The single patient enrolled in the trial showed no uptake in the liver tumor on the pretreatment scan and was dropped from the trial.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

At three months

Results posted on

2017-11-22

Participant milestones
Measure	Main Arm Enrolled patients are to undergo 3 acetate PET/CT examinations--the first within one month prior to radiotherapy, the second one month following, and the third three months following radiotherapy.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Radiotherapy Treatment Monitoring of Hepatocellular Carcinoma n=1 Participants All patients enrolled in the trial will undergo 3 PET/CT studies using 11C-acetate at the injected radiotracer. The patients will be imaged prior to their radiation therapy and at 1 and 3 months following the completion of their radiation therapy. They will also undergo an MRI scan of the liver at each of those time points. 11C-Acetate: The 11C-Acetate radiopharmaceutical will be administered intravenously at a dose of 20-40 mCi (0.74-1.5 GBq). There will be a total of three 11C-acetate radiopharmaceutical administrations for each patient
Age, Categorical <=18 years	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants
Sex: Female, Male Female	0 Participants n=1 Participants
Sex: Female, Male Male	1 Participants n=1 Participants
Region of Enrollment United States	1 Participants n=1 Participants
Number of participants	1 Participants n=1 Participants

Timeframe: At three months

The single patient enrolled in the trial showed no uptake in the liver tumor on the pretreatment scan and was dropped from the trial.

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Indiana University School of Medicine

Phone: 317 948-6340