Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging
Purpose
[18F] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE.
Condition
- Hepatocellular Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adult (> 18 years of age) patients with documented HCC tumor mass >3cm, who are scheduled to undergo TACE with additional selective internal radiation therapy (SIRT) - The appropriate criteria for inclusion for this patient population are: - Biopsy or radiological diagnosis of HCC (defined as Organ Procurement and Transplantation Network (OPTN*) Category 5 lesion either on CT or MRI) - Scheduled for TACE (using doxorubicin-eluting beads) + SBRT - Willingness to undergo PET/CT - Able to lie on the imaging table for up to 1 hour. - Able to provide signed informed consent. - Women with childbearing potential must have a negative urine Beta-Human Chorionic Gonadotropin (β-hCG) test day of procedure
Exclusion Criteria
- Estimated life expectancy <12 months or serious medical co-morbidities that would preclude definitive local therapy - Unable to lie on the imaging table - Age less than 18 years. - Pregnancy or lactation - Inability or unwillingness to provide informed consent. - Weight >500 lbs (the weight limit of the tomograph gantry table)
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT) |
FMISO imaging at baseline, post-TACE and post-SBRT |
|
More Details
- Status
- Terminated
- Sponsor
- University of Alabama at Birmingham
Study Contact
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.