A Pilot Study of Optical Molecular Imaging for Percutaneous Biopsy of Hepatocellular Carcinoma Using Indocyanine Green

NCT01962649 | Completed Early Phase 1 DMC

• 1 other identifier: 13-314
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is evaluating an imaging contrast agent called indocyanine green, also known as ICG, in combination with image guided liver biopsies. In this research study, the investigators are looking at the ability of ICG to collect within liver tumors during biopsy. The participant will be receiving a biopsy of their liver as a part of their medical care. By participating in this trial, the only additional requirement will be for the participant to come to the hospital on the day prior to their scheduled biopsy to receive an injection of ICG. During the biopsy, the investigator will measure the amount of ICG that is in the participant's liver tumor by using two experimental devices designed by the study investigators that shine light on tissue. One device consists of an imaging system attached to a small borescope that will go inside the participant's body during the biopsy. The second device shines light on the biopsy sample outside of the participant's body after the biopsy has been taken. The participant may undergo imaging with one or both of these devices.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Measurement of fluorescence intensity within focal hepatic lesions

  We hypothesize that HCC lesions will have significantly higher fluorescence intensity following ICG administration that normal/cirrhotic liver parenchyma. This will allow the proceduralist to recognize during the procedure whether the target lesion has been sampled accurately. We also hypothesize that OMI will characterize malignant lesions with \>90% accuracy prior to core biopsy, with standard of care histology and follow up imaging as the gold standard. Benign and malignant lesions will have significantly different ICG uptake to allow for their differentiation based on their ICG fluorescence signal intensity measured percutaneously.

  2 Years

Study Arms (1)

ICG & Optical Molecular Imaging

EXPERIMENTAL

All patients will receive a dose of ICG 0.5mg/kg, with a maximum dose of 40mg, one day prior to the scheduled procedure. The patients will then undergo a routine image-guided biopsy on the day of the procedure; immediately prior to obtaining the biopsy sample, fluorescence intensity within the target lesion will be measured by a handheld optical molecular imaging device, which will be passed through the biopsy needle. Once the core sample is obtained using a standard biopsy needle, the specimen will be imaged using an epifluorescence, point-of-care imaging system and will then be submitted for standard pathologic analysis.

Biological: ICG; Device: Optical molecular imaging

Interventions

ICG BIOLOGICAL

Also known as: IC-Green

ICG & Optical Molecular Imaging

Optical molecular imaging DEVICE

Also known as: OMI

ICG & Optical Molecular Imaging

Eligibility Criteria

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

You may qualify if:

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• Participants must be patients with imaging findings revealing a focal hepatic lesion suspicious for but not diagnostic of hepatocellular carcinoma. Eligible patients will be those whose imaging demonstrates an incompletely characterized focal hepatic lesion for which either ultrasound- or CT-guided biopsy is planned.
• For the negative control study, participants must be patients without known malignancy for whom either ultrasound- or CT-guided non-focal liver biopsy is planned to evaluate a non-malignant process.
• Fit for conscious sedation for percutaneous biopsy - American Society of Anesthesiologists (ASA) Class I or II.
• Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of ICG in participants \<18 years of age, children are excluded from this study but will be eligible for future pediatric Phase I trials.
• Life expectancy of greater than 6 months.
• ECOG performance status \<2 (see Appendix A).
• Participants must have normal organ and marrow function as defined below:
• Leukocytes \> 3,000/mcL
• Absolute neutrophil count \> 1,500/mcL
• Platelets \> 50,000/mcL
• The effects of ICG on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• Participants with ASA class III, IV, V.
• Participants with documented allergy to iodine or iodine containing compounds.
• Participants with documented allergy to sulfur containing compounds.
• History of adverse reactions to percutaneous procedures or sedatives for endoscopy or percutaneous biopsy.
• Participants taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, and probenecid.
• Participants who are unable to discontinue warfarin and clopidogrel anticoagulation 5 days prior to the procdure.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because there are unknown but potential teratogenic or abortifacient effects of ICG. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with ICG, breastfeeding should be discontinued if the mother is treated with ICG. These potential risks may also apply to other agents used in this study.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Radiological Society of North America: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

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

Study Officials

• Umar Mahmood, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 14, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

US (1)