Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies

A Feasibility Study to Evaluate the Combination of Electromagnetic Tracking and Optical Imaging With Indocyanine Green (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 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.

Study Overview

• Status: Terminated
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Device: Optical Molecular Imaging (OMI); Radiation: Indocyanine Green (ICG); Device: Electromagnetic Tracking

Detailed Description

• Pilot study to evaluate the combination of optical molecular imaging (OMI) and EM tracking in localizing intrahepatic lesions and assess the concordance between fluorescence ICG and histopathology for the diagnosis of liver cancer.
• Hepatocellular Carcinoma (HCC) is the 3rd most common cause of cancer globally with an increasing incidence worldwide. Percutaneous sampling of focal hepatic lesions is a cornerstone in management of patients with hepatic pathology. In a retrospective study of patients with small hepatic lesions, up to 45% of the lesions biopsied were insufficiently visualized and resulted to a false negative rate (defined as patients with benign biopsies who were subsequently found to have malignant lesions at the attempted site of biopsy). Thirty seven percent of those were for HCC.
• EM navigation and fusion of real-time images with pre-acquired scans has been used in hepatic biopsies at the NIH for more than 15 years. NIH / NCI clinical trials have performed fusion biopsies with EM tracking in > 2000 patients, > 40,000 biopsies over the past 12 years.
• Indocyanine green (ICG) is an FDA approved optical molecular imaging fluorescent dye used for visualization of cells and tissues. ICG has been used for decades in ophthalmology for imaging retinal blood vessels. ICG was FDA cleared in 1959 and has been widely used to assess liver function perioperatively. ICG is administered as an injection. Adverse effects are rare and most often minor.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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 Investigator, would limit compliance with study requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Detectable Indocyanine Green (ICG) Fluorescent Signal at the In-vivo Site of Biopsy	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.	Within 15 minutes from start of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance With the Histopathology and Indocyanine Green (ICG) Fluorescent Signal at the In-vivo Site of Biopsy Using a Combination of OMI and EM Tracking	The concordance with the histopathology and indocyanine green (ICG) fluorescent signal at the in-vivo site of biopsy using a combination of a handheld optical molecular imaging (OMI) and electromagnetic (EM) tracking and the target to background ratio (TBR) was obtained. Concordance is defined as a TBR ≥ 2. TBR is calculated by dividing the mean fluorescence intensity within the lesion by the mean fluorescence intensity within the adjacent liver parenchyma. Analysis was done as the median of all positive TBR readings.	Within 15 minutes from start of procedure
Participants With Concordance Between Histopathology Outcomes and Target to Background Ratio (TBR) Using ex Vivo Fluorescence Assessment	Number of participants whose ex vivo fluorescence assessment of biopsy cores obtained from the target lesion is in concordance with the histopathology result from the same cores. The point-of-care device camera was used to confirmed the presence or absence of ICG emission in biopsy cores from all patients.	Within 15 minutes from start of procedure

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)
• Investigators: Principal Investigator: Peter A Pinto, M.D., National Institutes of Health National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Actual): January 29, 2025
• Study Completion (Actual): January 29, 2025

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Optical Imaging; Hepatic Carcinoma; Indocyanine Green (ICG)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indocyanine Green
• Other Study ID Numbers: 200039; 20-CC-0039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified human data generated in this research for future research may be shared.
• IPD Sharing Time Frame: Two years after completion of study

IPD Sharing Access Criteria

De-identified data may be shared with the following:

• In an NIH-funded or approved public repository, www.clinicaltrials.gov.
• In Biomedical Translational Research Information System (BTRIS)
• In publication and/ or public presentations at the time of publication or shortly thereafter

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes