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

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

Detailed Description
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: FMISO
* Drug: FMISO
* Drug: FMISO


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT)<br>FMISO imaging at baseline, post-TACE and post-SBRT | Drug: FMISO<br>* FMISO PET/CT imaging at baseline<br>Drug: FMISO<br>* FMISO PET/CT post TACE<br>Drug: FMISO<br>* FMISO PET/CT post SBRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET). | Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia | At baseline | 
| Measure Changes in HCC Tumor Hypoxia and Blood Flow After Trans-arterial Chemoembolization (TACE), Prior to Radiotherapy. | Perform PET/CT imaging using FMISO post-TACE and prior to Stereotactic body radiation therapy (SBRT) to determine tumor hypoxia | 1 month post-TACE procedures and prior to SBRT | 
| Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy | Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia | 1 month post-SBRT |