Clinical trial NCT04258566: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Keywords: Hepatic Carcinoma
INDOCYANINE GREEN
Optical Imaging
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-02-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: ICG Fluorescene
timeFrame: Liver Parenchyma, Target Lesion, Ex Vivo
Secondary outcomes:
measure: In vivo fluorescence
timeFrame: At time of biopsy
measure: Exvivo fluorescence
timeFrame: Post biopsy
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Bradford J Wood, M.D.
role: PRINCIPAL_INVESTIGATOR
References: