Colorectal Polyps, Distal Colonic Lesions, High Risk Polyposis Syndrome
Conditions
Keywords
ICG, indocyanine green
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.
Detailed description
* Participants will be scheduled for their regular lower endoscopy. On the day of the procedure, participants will come to the endoscopy unit at Massachusetts General Hospital. After arriving, participants will receive an intravenous line and meet with the research doctor to go over the procedure. The participant will then be transferred to the endoscopy procedure room and be administered sedatives until they are comfortable to proceed with the procedure. * The research doctor will pass the flexible study sigmoidoscope into the lower part of the rectum. At this time, a dose of the ICG contrast agent will be administered through the intravenous line. Any areas that are suspicious will be photographed using the camera in the scope. We will also biopsy/remove any suspicious areas and send it to the pathologist as we normally do during endoscopy. * Over the course of the study procedure, small doses of ICG will be administered to help find any precancerous areas. Altogether, the study exam should not take more than 10 to 15 minutes.
Interventions
DRUGindocyanine green
Administered intravenously during endoscopic near-infrared (NIR) imaging
Sponsors
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Damon Runyon Cancer Research Foundation
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 18 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Neoplastic Lesions Detected | upto 15 mins |
Countries
United States
Participant flow
Recruitment details
Four participants were enrolled in the study, and of these four, one withdrew from the study. All participants were recruited between April 2010 and May 2012.
Participants by arm
| Arm | Count |
|---|---|
| ICG Injection Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | ICG Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 9.82 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Number of Neoplastic Lesions Detected
Time frame: upto 15 mins
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICG Injection | Number of Neoplastic Lesions Detected | 3 Lesions |