Fusion Imaging + Optical Imaging for Liver Biopsies
Trial Summary
What is the purpose of this trial?
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 imagingMedical historyPhysical examBlood test resultsParticipants 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 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.
Research Team
Bradford J Wood, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)
Eligibility Criteria
This trial is for adults who need a liver biopsy and may have hepatocellular carcinoma or other liver tumors. They must be able to consent, not pregnant, and without severe allergies to ICG or iodine-based contrasts. Those with serious illnesses that could limit study compliance are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-Biopsy Preparation
Participants will have a dye injected into a vein 24 hours before their biopsy and will be monitored for 30 minutes for any side effects.
Biopsy Procedure
Participants undergo a liver biopsy with the aid of electromagnetic tracking and optical imaging. They will have a CT scan to plan the needle's pathway and a small camera will be placed near the needle to take pictures of the liver.
Post-Biopsy Recovery
Participants will recover in the hospital for 4-6 hours after the biopsy procedure.
Follow-up
Participants are monitored for safety and effectiveness after the biopsy procedure.
Treatment Details
Interventions
- Indocyanine Green
- Optical Molecular Imaging
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institutes of Health Clinical Center (CC)
Lead Sponsor