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

The University of Alabama at Birmingham

Status and phase

Terminated

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: FMISO

Study type

Interventional

Funder types

Other

Identifiers

NCT03303469

F170519002

Details and patient eligibility

About

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

Full 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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)