Clinical trial NCT03303469: Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging
Official title: Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: [18F]Fluoromisonidazole (FMISO) Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

Eligibility 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)

Primary outcomes:
measure: Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET).
timeFrame: At baseline
measure: Measure Changes in HCC Tumor Hypoxia and Blood Flow After Trans-arterial Chemoembolization (TACE), Prior to Radiotherapy.
timeFrame: 1 month post-TACE procedures and prior to SBRT
measure: Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy
timeFrame: 1 month post-SBRT
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Advanced Imaging Facility
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Janis P O'Malley, M.D.
role: PRINCIPAL_INVESTIGATOR
References: