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Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies

NCT04258566 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-02-02

Study results available
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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.

Conditions

Interventions

DEVICE

Optical Molecular Imaging (OMI)

Tracks and localizes intrahepatic lesions

RADIATION

Indocyanine Green (ICG)

Fluorescent dye used for visualization of cells and tissue

DEVICE

Electromagnetic Tracking

Tracks and localizes intrahepatic lesions

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Peter A Pinto, M.D. · National Institutes of Health National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2025-01-29
Completion
2025-01-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04258566 on ClinicalTrials.gov