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NCT02471313 · ClinicalTrials.gov registry record · Phase 2
Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization
A Phase 2 study of Hepatocellular Carcinoma and Liver Cancer, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT02471313: Completed Phase 2 study of Hepatocellular Carcinoma and Liver Cancer, sponsored by National Institutes of Health Clinical Center (CC).
NCT02471313 is a Phase 2 study of Hepatocellular Carcinoma and Liver Cancer that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 3 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02471313, a Phase 2 study of Hepatocellular Carcinoma and Liver Cancer, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG [18F] FMISO
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-06-12 |
| Est. Completion | 2018-03-07 |
| Phase | Phase 2 |
What the finished NCT02471313 record still lists
NCT02471313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which [18F] FMISO is the first listed.
NCT02471313 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02471313 about?
NCT02471313 is a clinical study titled "Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization". 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. Researche...
What is the current status of trial NCT02471313?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2015-06-12. Estimated completion is 2018-03-07.
What conditions does trial NCT02471313 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Liver Cancer, HCC, Liver Neoplasm.
What interventions are being tested in trial NCT02471313?
The interventions under investigation include: [18F] FMISO (DRUG).
Who is sponsoring clinical trial NCT02471313?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02471313 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatocellular Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02471313's enrollment target sits among peer trials
3 145th of 145 higher than 1 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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