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

NCT02471313 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-04-23

Study results available
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Summary

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.

Conditions

Interventions

DRUG

[18F] FMISO

\[18F\] Fluromisonidazole, 1 h-(3-\[18F\]-fluro-2hydroxyl-propy10-2-nitro-imidazaole is an investigational positron emission tomography (PET) radiopharmaceutical for injection and used to visualize hypoxia imaging agent. Each patient will receive up to 10 mCi of \[18F\] FMISO PET imaging post TACE procedure.

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Elliot B Levy, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-12
Primary Completion
2018-03-07
Completion
2018-03-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02471313 on ClinicalTrials.gov