Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institutes of Health Clinical Center (CC)
Study ID
NCT04258566
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Optical Molecular Imaging (OMI) — DEVICE
    Tracks and localizes intrahepatic lesions
  • Indocyanine Green (ICG) — RADIATION
    Fluorescent dye used for visualization of cells and tissue
  • Electromagnetic Tracking — DEVICE
    Tracks and localizes intrahepatic lesions

Study Details

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.

Key Dates

Start date
Jan 27, 2022
Status verified
Jan 2026
Primary completion
Jan 29, 2025
Completion
Jan 29, 2025

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Optical plus fusion for liver biopsy
    Participants with diagnosed or suspected hepatocellular carcinoma (HCC) or metastatic intrahepatic cancer have the optical molecular imaging (OMI) performed with electromagnetic (EM) tracking during liver biopsy. Participants receive Indocyanine Green (ICG) 0.5 mg/kg, up to 40mg, intravenously 18-24hrs prior to scheduled biopsy.

Primary Outcome Measure

Participants With Detectable Indocyanine Green (ICG) Fluorescent Signal at the In-vivo Site of Biopsy [ Time Frame: Within 15 minutes from start of procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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