High Risk Polyposis SyndromeNCT01112514
Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract
A study testing indocyanine green in people with High Risk Polyposis Syndrome and Distal Colonic Lesions, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Risk Polyposis Syndrome, Distal Colonic Lesions, Colorectal Polyps
- What is being tested?
- indocyanine green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2010to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02214
About this study
Official title: A Pilot Study of Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract
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.
Read the 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.
- Being tested
- indocyanine green
- Keywords
- ICG, indocyanine green
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indocyanine greenDrug
Also called ICG, IC-Green
Administered intravenously during endoscopic near-infrared (NIR) imaging
| Study group | Role | What they receive |
|---|---|---|
| ICG Injection | Experimental | These participants underwent a colonoscopy after having an ICG injection. Receives: Drug: indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Neoplastic Lesions Detected
Measured: upto 15 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for High Risk Polyposis SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, National Cancer Institute (NCI), Damon Runyon Cancer Research Foundation
- Responsible party
- Principal investigator, Andrew T. Chan, MD, MPH, Massachusetts General Hospital
- Investigators
- Andrew T. Chan, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112514
- Sponsor's protocol ID
- 09-398
- Status last verified
- Jan 2014
- First submitted
- 27 Apr 2010
- Last updated
- 24 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT01112514
- Acronym / sponsor ID
- 09-398
- Keywords
- ICG, indocyanine green
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, National Cancer Institute (NCI), Damon Runyon Cancer Research Foundation
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Posted 24 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG Injection | Experimental | Drug: indocyanine greenThese participants underwent a colonoscopy after having an ICG injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indocyanine greenAlso: ICG, IC-GreenAdministered intravenously during endoscopic near-infrared (NIR) imaging | Drug | ICG Injection |
Primary outcome
Number of Neoplastic Lesions Detected
Time frame: upto 15 mins
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew T. Chan, MD, MPH principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing indocyanine green in people with High Risk Polyposis Syndrome and Distal Colonic Lesions, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Neoplastic Lesions Detected (time frame: upto 15 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2014.