NCT05250895

BOLD MRI and FMISO PET for the Assessment of Hypoxic Tumor Microenvironment in Patients with Oligometastatic Liver Cancer Undergoing Yttirum-90 Selective Internal Radiation Therapy

Molecular Imaging of the Hypoxic Tumor Microenvironment to Predict Response to Yttirum-90 Selective Internal Radiation Therapy in Hepatocellular Carcinoma- Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This early phase I trial evaluates the use of hypoxia (lack of oxygen) as a measure in determining the outcome of Y90 selective internal radiation therapy in patients with liver cancer that has spread to a limited number of sites (oligometastatic). Radioembolization with Y90 is a minimally invasive procedure that combines embolization and radiation therapy to treat metastatic liver cancer. Tiny beads filled with radioactive isotope Y-90 are placed inside the blood vessel that provide blood supply to the tumor. This will block the blood flow to the tumor cells while providing a high radiation dose without harming healthy normal tissue.

Detailed description

PRIMARY OBJECTIVE: I. To investigate the variability of hypoxia in hepatocellular carcinoma (HCC) as quantified by blood oxygen level-dependent (BOLD) magnetic resonance imaging (MRI) and dynamic 18F-Fluoromisonidazole (FMISO) positron emission tomography (PET). SECONDARY OBJECTIVES: I. Investigate whether hypoxia, as quantified by BOLD MRI, dynamic FMISO PET, HIF-1alpha and VEGF expression, predicts HCC response to yttrium-90 (Y90) selective internal radiation therapy (SIRT). II. Assess whether hypoxia quantification by BOLD MRI, dynamic FMISO, HIF-1alpha or VEGF expression individually or in combination more accurately predict the degree of HCC tumor response to Y90 SIRT. III. Compare the tumor dose response threshold between hypoxic and non-hypoxic HCCs treated with Y90 SIRT. OUTLINE: Patients receive 18F-fluoromisonidazole intravenously (IV) and undergo PET and dynamic contrast enhanced (DCE) MRI within 30 days before beginning Y90 SIRT. Patients undergo Y90 SIRT per standard of care. After completion of study intervention, patients are followed up at 90 days, and then every 12 weeks thereafter.

Conditions

• BCLC Stage a Hepatocellular Carcinoma
• BCLC Stage B Hepatocellular Carcinoma
• BCLC Stage C Hepatocellular Carcinoma
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
OTHER	18F-Fluoromisonidazole	Given IV
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Dynamic Contrast-Enhanced Magnetic Resonance Imaging	Undergo DCE MRI
PROCEDURE	Positron Emission Tomography	Undergo PET

Timeline

• Start date: 2022-04-28
• Primary completion: 2025-02-26
• Completion: 2025-02-26
• First posted: 2022-02-22
• Last updated: 2025-03-13

Locations

1 site across 1 country: United States