Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies

NCT04258566 | Terminated Results FDA Device

• 2 other identifiers: 20003920-CC-0039
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Hepatocellular Carcinoma

Keywords

Hepatic Carcinoma; Indocyanine Green (ICG); Optical Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  Within 15 minutes from start of procedure

• Participants With Concordance Between Histopathology Outcomes and Target to Background Ratio (TBR) Using ex Vivo Fluorescence Assessment

  Within 15 minutes from start of procedure

Study Arms (1)

Optical plus fusion for liver biopsy

EXPERIMENTAL

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); Radiation: Indocyanine Green (ICG); Device: Electromagnetic Tracking

Interventions

Indocyanine Green (ICG) RADIATION

Fluorescent dye used for visualization of cells and tissue

Optical plus fusion for liver biopsy

Electromagnetic Tracking DEVICE

Tracks and localizes intrahepatic lesions

Optical plus fusion for liver biopsy

Optical Molecular Imaging (OMI) DEVICE

Tracks and localizes intrahepatic lesions

Optical plus fusion for liver biopsy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Study was prematurely terminated due to recruitment difficulty.

Results Point of Contact

• Title: Dr Peter A Pinto
• Organization: National Cancer Institute (NCI)

pp173u@nih.gov

1-240-858-3700

Study Officials

• Peter A Pinto, M.D.

  National Institutes of Health National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 6, 2020
• Study Start: January 27, 2022
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2025
• Last Updated: February 2, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Two years after completion of study
• 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

Locations

US (1)