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

Stanford University

Status and phase: Completed; Phase 2

Conditions: Liver Cirrhosis; Adult Liver Carcinoma

Treatments: Drug: 18F-Fluoromisonidazole; Diagnostic Test: Positron Emission Tomography; Procedure: Arterial Embolization; Diagnostic Test: Computed Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02695628

IRB-29768

P30CA124435 (U.S. NIH Grant/Contract)

NCI-2016-00041 (Registry Identifier)

HEP0055 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Histopathologic or imaging and clinical features of tumor(s) diagnostic for hepatocellular carcinoma with at least one tumor >= 1.5 cm; imaging features diagnostic for hepatocellular carcinoma will be defined as Liver Imaging Reporting and Data System (LIRADS) 4 or greater
• Total bilirubin < 3.0
• Child Pugh A or B
• Tumor amenable to transcatheter arterial embolization
• Able to provide informed consent

Exclusion criteria

• Uncontrolled large ascites
• Main or segmental portal vein thrombosis
• Locoregional treatment of hepatocellular carcinoma within the prior 3 months or chemotherapy within the previous 3 months
• Inability or contraindication to undergo transcatheter arterial embolization
• Inability to lay flat for at least 2 consecutive hours
• Severe acute illness
• Uncontrolled chronic illness such as hypertension, diabetes, or heart failure
• Contraindication to CT or MRI contrast
• Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Diagnostic (18F-fluoromisonidazole, PET/CT, embolization)

Experimental group

Description:

Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.

Treatment:

Diagnostic Test: Positron Emission Tomography

Procedure: Arterial Embolization

Diagnostic Test: Computed Tomography

Drug: 18F-Fluoromisonidazole