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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-13

Study Completion Date

2018-10-31

Brief Summary

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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

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Detailed Description

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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

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Adult Liver Carcinoma Liver Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

18F-Fluoromisonidazole

Intervention Type DRUG

Undergo \[18F\] FMISO PET/CT

Arterial Embolization

Intervention Type PROCEDURE

Undergo transcatheter arterial embolization

Computed Tomography

Intervention Type DIAGNOSTIC_TEST

Undergo \[18F\] FMISO PET/CT

Positron Emission Tomography

Intervention Type DIAGNOSTIC_TEST

Undergo \[18F\] FMISO PET/CT

Interventions

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18F-Fluoromisonidazole

Undergo \[18F\] FMISO PET/CT

Intervention Type DRUG

Arterial Embolization

Undergo transcatheter arterial embolization

Intervention Type PROCEDURE

Computed Tomography

Undergo \[18F\] FMISO PET/CT

Intervention Type DIAGNOSTIC_TEST

Positron Emission Tomography

Undergo \[18F\] FMISO PET/CT

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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18F-MISO 18F-Misonidazole FMISO TAE Transarterial Embolization CAT CAT Scan Computerized Axial Tomography Computerized Tomography CT CT SCAN tomography Medical Imaging, Positron Emission Tomography PET PET SCAN Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No