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NCT04258566 · ClinicalTrials.gov registry record · NA
Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies
A NA study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT04258566: Clinical Trial NA study, sponsored by National Institutes of Health Clinical Center (CC).
NCT04258566 is a NA study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04258566, a NA study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: Liver cancer is the sixth most common cancer worldwide. Diagnosing liver cancer usually requires a liver sample. Getting the best sample helps determine whether cancer is present and what kind of cancer it is. But sampling can be difficult. This study will look at combining two devices to provide better liver samples. Objective: To see if combining fusion imaging and optical imaging can better sample areas of concern in the liver and determine the presence of disease. Eligibility: People ages 18 and older who need a liver biopsy as part of diagnosis or treatment. Design: Participants will be screened with: * Review of imaging * Medical history * Physical exam * Blood test results Participants will have a dye injected into a vein 24 hours before their biopsy. They will be monitored for 30 minutes for any side effects. For the biopsy, participants skin will be numbed. They may have stickers placed on their belly to help guide the needle. They will have a CT scan to plan the needle s pathway. For the scan, they will lie in a machine that takes pictures of the body. A small camera will be placed near the needle to take pictures of the liver. A medical global positioning system (GPS) tracking system will be used. This will guide the needle into the area of the participant s liver where the biopsy will be taken. After the biopsy, participants will recover in the hospital for 4 6 hours. After the procedure, researchers will take the participants biopsy tissue and look at it to try to compare new ways to picture the sample.
Primary Outcome
Number of Participants with detectable indocyanine green (ICG) fluorescent signal at the in-vivo site of biopsy using a combination of optical molecular imaging (OMI) and electromagnetic (EM) tracking. Real-time EM navigation effectively guided the needle to the vicinity of the target lesion, allowing subsequent OMI to be performed to provide in situ confirmation of ICG presence.
Interventions
- DEVICE Optical Molecular Imaging (OMI)
- RADIATION Indocyanine Green (ICG)
- DEVICE Electromagnetic Tracking
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-01-27 |
| Est. Completion | 2025-01-29 |
| Phase | NA |
Why NCT04258566 stopped before completion
NCT04258566 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which Optical Molecular Imaging (OMI) is the first listed.
NCT04258566 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04258566 about?
NCT04258566 is a clinical study titled "Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies". Background: Liver cancer is the sixth most common cancer worldwide. Diagnosing liver cancer usually requires a liver sample. Getting the best sample helps determine whether cancer is present and what kind of cancer it is. But sampling can be difficult. This study will look at combining two devices ...
What is the current status of trial NCT04258566?
This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2022-01-27. Estimated completion is 2025-01-29.
What interventions are being tested in trial NCT04258566?
The interventions under investigation include: Optical Molecular Imaging (OMI) (DEVICE), Indocyanine Green (ICG) (RADIATION), Electromagnetic Tracking (DEVICE).
Who is sponsoring clinical trial NCT04258566?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04258566's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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