Status:
TERMINATED
Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03303469
Start Date
October 30 2017
End Date
January 6 2021
Last Update
February 21 2021
Active Locations (1)
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1
UAB Advanced Imaging Facility
Birmingham, Alabama, United States, 35294