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

February 15, 2021 updated by: Janis P. O'Malley, MD, University of Alabama at Birmingham

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Advanced Imaging Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional 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)
FMISO imaging at baseline, post-TACE and post-SBRT
Drug: FMISO
FMISO PET/CT imaging at baseline
Drug: FMISO
FMISO PET/CT post TACE
Drug: FMISO
FMISO PET/CT post SBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET).
Time Frame: At baseline
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.
Time Frame: 1 month post-TACE procedures and prior to SBRT
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
Time Frame: 1 month post-SBRT
Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia
1 month post-SBRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Janis P O'Malley, M.D., University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2017

Primary Completion (Actual)

January 6, 2021

Study Completion (Actual)

January 6, 2021

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 6, 2017

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F170519002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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