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

About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Experimental
ICG & Optical Molecular Imaging
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.