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

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.

Inclusion Criteria:

- Adult (> 18 years of age) patients with documented HCC tumor mass >3cm, who are
scheduled to undergo TACE with additional 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 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)