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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03303469
• Other study ID #: F170519002
• Status: Terminated
• Phase: Phase 2
• Start date: October 30, 2017
• Est. completion date: January 6, 2021

Study information

• Verified date: February 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 6, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (ß-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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• FMISO
FMISO PET/CT imaging at baseline
• FMISO
FMISO PET/CT post TACE
• FMISO
FMISO PET/CT post SBRT

Locations

Country	Name	City	State
United States	UAB Advanced Imaging Facility	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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