NCT02695628

[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer

Assessment of Treatment-Induced Tissue Hypoxia After Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Feasibility Study With [18F]FMISO PET/CT

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies how well 18F-fluoromisonidazole (\[18F\]FMISO) positron emission tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor. \[18F\]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that have a low level of oxygen, and the radiation given off by \[18F\]FMISO is picked up by a PET scan and this may help researchers learn whether changes occur in the tumors after treatment, which can help decide how well the treatment worked earlier than is currently possible

Detailed description

PRIMARY OBJECTIVES: I. Determine the variability of 18F FMISO uptake in hepatocellular carcinoma (HCC) tumors compared to normal liver after transcatheter arterial embolization by determining the difference in the mean of the maximum standardized uptake value (SUVmax) and tumor-to-liver ratio (TLR) of a region of normal liver and of up to 5 index tumors. SECONDARY OBJECTIVES: I. Determine if areas of tumor recurrence as determined by CT or magnetic resonance imaging (MRI) within a 6 month period after transcatheter arterial embolization show evidence of increased 18F FMISO labeling on the initial post treatment 18F FMISO PET/CT. II. Determine the variability in SUVmax and TLR of untreated (non embolized) HCC lesions compared to normal liver by determining the difference in the mean of the SUVmax and TLR of normal liver and tumor. III. Determine any toxicities related to \[18F\]FMISO use for PET/CT. OUTLINE: Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole intravenously (IV) and undergo PET/CT scans within 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment. After completion of treatment, patients are followed up at 2 and 3 months.

Conditions

• Adult Liver Carcinoma
• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	18F-Fluoromisonidazole	Undergo \[18F\] FMISO PET/CT
PROCEDURE	Arterial Embolization	Undergo transcatheter arterial embolization
DIAGNOSTIC_TEST	Computed Tomography	Undergo \[18F\] FMISO PET/CT
DIAGNOSTIC_TEST	Positron Emission Tomography	Undergo \[18F\] FMISO PET/CT

Timeline

• Start date: 2016-09-13
• Primary completion: 2018-04-30
• Completion: 2018-10-31
• First posted: 2016-03-01
• Last updated: 2024-01-31
• Results posted: 2019-05-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study