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

Phase 2

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: FMISO

• Registration Number: NCT03303469
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-06
• Study Start: 2017-10-30
• Primary Completion: 2021-01-06
• Study Completion: 2021-01-06
• Results First Submitted: 2021-01-27
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-15
• Results First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT)	FMISO	FMISO imaging at baseline, post-TACE and post-SBRT

Primary Outcome Measures

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

Trial Locations

Locations (1)

UAB Advanced Imaging Facility; 🇺🇸 Birmingham, Alabama, United States