Conditions: Hepatocellular Carcinoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

Brief summary:
\[18F\] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE.

Detailed description:
This Phase II study will investigate the utility of \[18F\] FMISO in patients with hepatocellular carcinoma (HCC). This trial is designed to test the hypothesis that PET determined \[18F\]FMISO uptake will indicate tumor hypoxia in patients with HCC treated with trans-arterial chemo-embolization (TACE). We anticipate that \[18F\] FMISO PET/CT will advance our understanding of the role of hypoxia in HCC prior to treatment and that this knowledge will help design newer combination therapeutic trials for better treatment outcomes. \[18F\] FMISO PET/CT provides three parameters, tissue hypoxic volume (HV), maximum tissue to blood uptake ratio (T:Bmax) and tumor blood flow. Both pre-and post-therapy images will be examined to investigate changes in these parameters during the course of TACE treatment.

Arms:
arm 1: FMISO imaging at baseline, post-TACE and post-SBRT

Interventions: intervention 1: FMISO intervention 2: FMISO intervention 3: FMISO
Intervention descriptions: intervention 1: FMISO PET/CT imaging at baseline intervention 2: FMISO PET/CT post TACE intervention 3: FMISO PET/CT post SBRT

Protocol document:
Prot_SAP_001.pdf: 
Hypoxic Changes in Hepatocellular Carcinoma (HCC) 
Following Trans Arterial Chemo Embolization and 
Stereotactic Radiation: [18F]Fluoromisonidazole (FMISO) 
Imaging 
Study Protocol & Statistical Analysis Plan 
NCT03303469
July 30, 2020 
Janis O'Malley, M.D., Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294