TerminatedNot Applicable

Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies

Stopped: Recruitment difficulty

United States7 participantsStarted 2022-01-27

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: In order be eligible to participate in this study, an individual must meet all of the following criteria: * Patients must have imaging findings consistent with hepatocellular carcinoma or other liver neoplasms or metastasis, for whom image-guided percutaneous biopsy is planned as clinically indicated or Institutional Review Board (IRB)-approved under a separate research protocol. * Patients must have at least one lesion that can readily be biopsied per Principal Investigator. * Age \>18 years. * Patients must have the ability to understand and the willingness to sign a written informed consent document. * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they verbally report amenorrhea for 12 months without an alternative medical cause, or have had surgery or received chemicals to induce menopause. EXCLUSION CRITERIA: * History of hypersensitivity reactions to Indocyanine Green (ICG), iodinated contrast, or sulfur-containing compounds. * Pregnant women and nursing mothers are excluded from this study because of exposure to radiation from CT scanning associated with the biopsy * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the Principal …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Participants With Detectable Indocyanine Green (ICG) Fluorescent Signal at the In-vivo Site of Biopsy

Timeframe: Within 15 minutes from start of procedure

Trial details

NCT IDNCT04258566

SponsorNational Institutes of Health Clinical Center (CC)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-01-29

Results submitted2026-01-14

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials