Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization

Completed · Phase 2

Conditions studied: Liver Cancer, Liver Neoplasm, Hepatocellular Carcinoma, HCC

In brief

Background: \- Treatment for liver cancer can include surgery, transplant, and chemotherapy. It can also include other minimally invasive tumor treatments such as transarterial chemoembolization (TACE). TACE treatment for liver cancer helps control the cancer but is not considered a cure. Researchers want to learn more about the effects of TACE on liver tumors and surrounding tissue. To do this, they will use a positive emission test (PET) and a radioactive tracer called \[18F\] FMISO. Objectives: \- To see if \[18F\] FMISO is useful for evaluating what happens to liver tumors and surrounding tissue after TACE. Eligibility: \- People age 18 and older with liver cancer who have been approved to have TACE. Design: * Participants will meet with a study researcher to see if they can take part in the study. * Participants will have TACE under a separate NCI protocol or at a hospital other than the NIH Clinical Center. * Before and after TACE, participants will have a CT and MRI of the abdomen. For these scans, they will lie in a machine that takes pictures of their body. They will also have blood tests and a physical exam. * The \[18F\] FMISO imaging study will be performed at NIH only. * Participants will have an intravenous catheter placed in their arm (if they do not have one). The \[18F\] FMISO tracer will be injected. * Participants will have PET-CT scans. Each scan will take about 30 minutes. * Some participants will also have \[18F\] FMISO and PET-CT scans before TACE. * As part of standard care for TACE, participants will have CT and MRI scans at regular intervals. This will evaluate tumor response.

Key facts

Study ID

NCT02471313

Run by

National Institutes of Health Clinical Center (CC)

People needed

3

Starts

2015-06-12

Expected to finish

2018-03-07

Last updated by the study team

2019-04-23

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who have received prior TACE treatment
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to misonidazole or other agents used in study.
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients of childbearing age must not be pregnant. The effects of [(18)F]FMISO on the developing human fetus are unknown. Pregnancy is a contraindication for TACE.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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