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

NCT ID: NCT03303469

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2021-01-06

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT)

FMISO imaging at baseline, post-TACE and post-SBRT

Group Type: EXPERIMENTAL

FMISO

Intervention Type: DRUG

FMISO PET/CT imaging at baseline

FMISO

Intervention Type: DRUG

FMISO PET/CT post TACE

FMISO

Intervention Type: DRUG

FMISO PET/CT post SBRT

Interventions

FMISO

FMISO PET/CT imaging at baseline

Intervention Type: DRUG

FMISO

FMISO PET/CT post TACE

Intervention Type: DRUG

FMISO

FMISO PET/CT post SBRT

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Janis P. O'Malley, MD

Principal Investigator, Professor of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janis P O'Malley, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Advanced Imaging Facility

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

F170519002

Identifier Type: -

Identifier Source: org_study_id