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Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies

Primary Purpose

Hepatocellular Carcinoma

Status

Enrolling by invitation

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Optical Molecular Imaging

Indocyanine Green

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Hepatic Carcinoma, INDOCYANINE GREEN, Optical Imaging

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

National Institutes of Health Clinical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Suspected hepatic malignancy

Arm Description

Malignancy determination of new onset hepatic lesion

Outcomes

Primary Outcome Measures

ICG Fluorescene

Measurements will be obtained during hepatic biopsy procedure

Secondary Outcome Measures

In vivo fluorescence

Assess concordance of ICG fluorescence at invivo site of biopsy with presence or absence of malignancy as defined by pathology

Exvivo fluorescence

Assess concordance of ICG fluorescence at exvivo site of biopsy with presence or absence of malignancy as defined by pathology

Full Information

NCT ID

NCT04258566

First Posted

February 5, 2020

Last Updated

October 7, 2023

Sponsor

National Institutes of Health Clinical Center (CC)

1. Study Identification

Unique Protocol Identification Number

NCT04258566

Brief Title

Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies

Official Title

A Feasibility Study to Evaluate the Combination of Electromagnetic Tracking and Optical Imaging With Indocyanine Green (ICG) for Hepatic Biopsies

Study Type

Interventional

2. Study Status

Record Verification Date

October 6, 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

January 27, 2022 (Actual)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institutes of Health Clinical Center (CC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

Hepatic Carcinoma, INDOCYANINE GREEN, Optical Imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Suspected hepatic malignancy

Arm Type

Experimental

Arm Description

Malignancy determination of new onset hepatic lesion

Intervention Type

Device

Intervention Name(s)

Optical Molecular Imaging

Intervention Description

Tracks and localizes intrahepatic lesions

Intervention Type

Radiation

Intervention Name(s)

Indocyanine Green

Intervention Description

Fluorescent dye used for visualization of cells and tissue

Primary Outcome Measure Information:

Title

ICG Fluorescene

Description

Measurements will be obtained during hepatic biopsy procedure

Time Frame

Liver Parenchyma, Target Lesion, Ex Vivo

Secondary Outcome Measure Information:

Title

In vivo fluorescence

Description

Assess concordance of ICG fluorescence at invivo site of biopsy with presence or absence of malignancy as defined by pathology

Time Frame

At time of biopsy

Title

Exvivo fluorescence

Description

Assess concordance of ICG fluorescence at exvivo site of biopsy with presence or absence of malignancy as defined by pathology

Time Frame

Post biopsy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bradford J Wood, M.D.

Organizational Affiliation

National Institutes of Health Clinical Center (CC)

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

12. IPD Sharing Statement

Links:

URL

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2020-CC-0039.html

Description

NIH Clinical Center Detailed Web Page

Learn more about this trial

Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies

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