Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract

NCT01112514 | Completed Results DMC

• 1 other identifier: 09-398
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

Standard white light endoscopy involves the passage of a thin, flexible camera into the colon from the anus. Although standard white light endoscopy can detect most polyps and precancerous areas in the gastrointestinal tract and colon, many studies have shown that even the most experienced doctors, under optimal conditions, can miss up to 15-25% of precancerous areas. Thus, there remains a clear need to develop new methods of improving standard white light endoscopy. We are investigating whether indocyanine green (ICG) can serve to highlight areas which are precancerous when the colon is visualized with a special cameral which shines fluorescent light. Information from other studies suggests that this ICG agent may help to visualize blood vessels flowing to precancerous areas in the colon. We are looking at the ability of ICG, in combination with an endoscope which shines fluorescent light, to visualize precancerous areas in the colon.

Conditions

High Risk Polyposis Syndrome; Distal Colonic Lesions; Colorectal Polyps

Keywords

ICG; indocyanine green

Outcome Measures

Primary Outcomes (1)

• Number of Neoplastic Lesions Detected

  upto 15 mins

Study Arms (1)

ICG Injection

EXPERIMENTAL

These participants underwent a colonoscopy after having an ICG injection.

Drug: indocyanine green

Interventions

indocyanine green DRUG

Administered intravenously during endoscopic near-infrared (NIR) imaging

Also known as: ICG, IC-Green

ICG Injection

Eligibility Criteria

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

You may qualify if:

• Participants will include patients with high risk polyposis syndromes with planned routine endoscopic surveillance for neoplasia or patients with planned endoscopic evaluation of distal colonic lesions suspicious for colorectal polyps or cancer detected on abdominal imaging
• Fit for conscious sedation or monitored anesthesia care for colonoscopy-American Society of Anesthesiologists (ASA) Class I or II
• years of age or older
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
• Negative human chorionic gonadotropin (HCG) test for women of child-bearing age. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation

You may not qualify if:

• Participants with AsA class III, IV, V
• Documented allergy to iodine, iodine-containing compounds of ICG
• Documented allergy to sulfur containing compounds
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG
• History of adverse reactions to endoscopy or sedatives for endoscopy
• Pregnant or breast-feeding women
• Participants who are unable to discontinue warfarin anticoagulation 5 days before the procedure
• Participants taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• National Cancer Institute (NCI): collaborator
• Damon Runyon Cancer Research Foundation: collaborator

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Andrew T. Chan
• Organization: Massachusetts General Hospital

achan@partners.org

617 726 3212

Study Officials

• Andrew T. Chan, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: April 28, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2013
• Last Updated: February 24, 2014
• Results First Posted: February 24, 2014

Record last verified: 2014-01

Locations

US (2)