Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization
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|ClinicalTrials.gov Identifier: NCT02471313|
Recruitment Status : Completed
First Posted : June 15, 2015
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
- 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.
- To see if [18F] FMISO is useful for evaluating what happens to liver tumors and surrounding tissue after TACE.
- People age 18 and older with liver cancer who have been approved to have TACE.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer Liver Neoplasm Hepatocellular Carcinoma HCC||Drug: [18F] FMISO||Phase 2|
- TACE is the standard therapy for inoperable primary liver cancers or tumor control prior to transplantation. The mechanisms for TACE s failure remains poorly understood.
- Although acute hypoxia and significant tumor necrosis occurs following TACE, the tumor adaptive response and localization for such have not been well characterized.
- Imaging tools using a hypoxia-specific tracer [(18)F] FMISO may help identify the pattern and distribution of acute post-TACE tumor hypoxia relative to demonstrated tumor progression.
- The primary hypothesis of this study states that tumor progression post-TACE arises from changes in tumor phenotype induced by treatment-related hypoxia superimposed on the dynamic process of underlying tumor hypoxia.
-To determine the feasibility of hypoxic tumor identification despite relatively high liver background signal, and describe patterns of tumor hypoxia in the immediate post-TACE treatment period using PET imaging [(18)F] MISO uptake registered with cross-sectional imaging.
- Patients greater than or equal to 18 years with inoperable primary hepatic malignancy or hepatic-dominant metastatic-disease and be otherwise eligible to receive TACE treatment. Patients with hepatocellular carcinoma should have intermediate stage disease according to the BCLC staging system (Stage A4 or B).
- Patients must not have had chemotherapy- or radiation therapy to liver for at least 2 weeks prior to starting study treatments.
- Patients must not have an acute, critical illness.
- Patients must not be pregnant
- Able to understand and be willing to sign a written informed consent
- Fifteen patients with primary or metastatic liver malignancy will be enrolled into this pilot, non-randomized, open study of the feasibility of using (18)F-fluoromisonidazole PET scanning to determine hypoxic tumor identification and localization, and to identify the pattern and distribution of acute post-TACE tumor hypoxia relative to demonstrated tumor progression.
- Twenty-four to seventy-two hours after standard of care TACE, patients will undergo
PET scanning using 0.1mCi/kg (maximum 10mCi) of (18)F-fluoromisonidazole [(18)F] MISO).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of an Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization|
|Study Start Date :||June 12, 2015|
|Actual Primary Completion Date :||March 7, 2018|
|Actual Study Completion Date :||March 7, 2018|
Experimental: [18F] FMISO PET scan
Patients with primary hepatic malignancy who underwent [18F] FMISO PET Scan following transarterial chemoembolization (TACE) procedure
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.
Other Name: FMISO
- Number of Participants for Which Uptake of [18F]-FMISO Was Successful and Hypoxic Tumors Were Observed During PET Scan Imaging Post TACE Procedure [ Time Frame: up to 72 hours after injection of [18F] FMISO ]A single dose of study imaging agent [18F] FMISO was administered following the TACE procedure. PET Scan imaging was then performed to evaluate if hypoxic tumor identification were observable following administration of study imaging agent. Power and significance calculations are not applicable to this small sample feasibility study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471313
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Elliot B Levy, M.D.||National Institutes of Health Clinical Center (CC)|