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

Hepatocellular Carcinoma Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

Before the research starts (screening): After signing this consent form, the participant will be asked to undergo some screening tests or procedures to find out if the participant can be in the research study. Many of these tests and procedures are likely to be part of regular care and may be done even if it turns out that the participant does not take part in the research study. If the participant has had some of these tests or procedures recently, they may or may not have to be repeated.

• A medical history, which includes questions about the participant's health, current medications, and any allergies.

• Performance status, which evaluates how the participant is able to carry on with their usual activities.

• An assessment of your liver by X-ray, ultrasound, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans.

• Anesthesia score, which evaluates how the participant tolerates the sedation given with biopsies.

• Blood tests.

If these tests show that the participant is eligible to participate in the research study, the participant will receive the study agent. If the participant does not meet the eligibility criteria, then the participant will not be able to participate in this research study.

After the screening procedures confirms that the participant is eligible to participate in the research study: The participant will be scheduled for their regular CT- or ultrasound-guided liver biopsy. On the day prior to the procedure, the participant will come to our Interventional Radiology waiting area at Massachusetts General Hospital. After the participant arrives, the participant will be interviewed by a research doctor and receive a dose of ICG intravenously. The participant will be monitored for 30 minutes after the injection, and after this time, the participant will be free to leave. On the day of the procedure, the participant will come back to the Interventional Radiology waiting area. After the participant arrives, the participant will receive an intravenous line. The participant may also have some blood drawn (no more that 4 tablespoons) for any tests needed in addition to blood work done before the participant was enrolled in the study. The participant will then meet again with the research doctor, who will go over the procedure with the participant and as usual obtain their consent to have the standard liver biopsy. The nurse will begin administering the sedatives until the participant is comfortable to proceed with the procedure. The research doctor and his assistant will advance a hollow biopsy needle through the skin and into the lesion in the liver. A miniature endoscope, small enough to fit through the hollow center of the biopsy needle, will then be passed through the needle so that the tip of the endoscope is within the lesion. The fluorescence within the lesion will be measured with the endoscope by a special camera attached to the back of the endoscope. The endoscope will then be removed, and the lesion will be biopsied with a standard biopsy needle. If the participant is undergoing a biopsy of the liver to obtain a sample of their liver tissue and not a specific area in the liver, the endoscopic imaging described above will not be performed. The biopsy will be performed in the usual way. Once the biopsy is performed, the sample of tissue from the biopsy will be imaged by a special camera and computer that will be within the procedure room. The added steps for this trial should only add approximately 5 minutes to the procedure time.

After the procedure: After the procedure is complete, the investigator will bring the participant to the recovery room so that the participant can sleep off the sedative medications. Throughout this time, the participant will be observed by a nurse, and vital signs will be monitored. The participant will be given the usual post-procedure instructions. The investigator would like to keep track of your medical condition after the procedure to make sure no side effects have occurred. The investigator would like to do this by calling the participant on the telephone the day after the procedure and 1 week after the procedure. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT01962649
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: Early Phase 1
• Start date: October 2013
• Completion date: April 2014