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

NCT03303469 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: F170519002
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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

EXPERIMENTAL

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

Drug: FMISO

Interventions

FMISO DRUG

FMISO PET/CT imaging at baseline

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Advanced Imaging Facility

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

fluoromisonidazole

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Janis O'Malley
• Organization: The University of Alabama at Birmingham

jomalley@uabmc.edu

205-934-6504

Study Officials

• Janis P O'Malley, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Radiology

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: October 6, 2017
• Study Start: October 30, 2017
• Primary Completion: January 6, 2021
• Study Completion: January 6, 2021
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Locations

US (1)