An Early Phase 1 interventional study of 18F-Fluoromisonidazole and Biopsy in BCLC Stage a Hepatocellular Carcinoma, BCLC Stage B Hepatocellular Carcinoma and BCLC Stage C Hepatocellular Carcinoma, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Emory University · Early Phase 1, Interventional, and Diagnostic
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 9 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Exclusion Criteria:
Patients receive 18F-fluoromisonidazole IV and undergo PET and DCE MRI within 30 days before beginning Y90 SIRT. Patients undergo Y90 SIRT per standard of care.
Other: 18F-Fluoromisonidazole · Procedure: Biopsy · Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging · Procedure: Positron Emission Tomography
Given IV
Also known as: 18F-MISO, 18F-Misonidazole, FMISO
Undergo biopsy
Also known as: BIOPSY_TYPE, Bx
Undergo DCE MRI
Also known as: DCE, DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Undergo PET
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
To investigate the variability of hypoxia in HCC at baseline as quantified by BOLD MRI
Threshold \<1.0 R2 tumor to normal ratio (no unit) as a cutoff for hypoxia
Time frame: From weeks 1-2 up to 1 year
To investigate the variability of hypoxia in HCC at baseline as quantified by immunohistochemistry
The staining intensity will be measured and scored with four scales: no staining=0, weak staining=1, moderate staining=2, and strong staining=3. The final staining score will be obtained by stained stumor area% x positive tumor cells % x staining intensity. The tumors will be then categorized as hypoxic (scores 8 to 16) vs. non-hypoxic (scores 0 to 7) (no units).
Time frame: From weeks 1-2 up to 1 year
Determine whether hypoxia is predictor of response in HCC treated with Y90 SIRT
Treatment Response Assessment using mRECIST
Time frame: From week 0 up to 1 year
Treatment response
Assessed using modified Response Evaluation Criteria in Solid Tumors.
Time frame: From week 0 Up to 1 year
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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