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

• Status: Terminated
• Trial end date: 2021-01-06
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham

Criteria

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)