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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| National Cancer Institute (NCI) | NIH |
| Damon Runyon Cancer Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG Injection | Experimental | These participants underwent a colonoscopy after having an ICG injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indocyanine green | Drug | Administered intravenously during endoscopic near-infrared (NIR) imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Neoplastic Lesions Detected | upto 15 mins |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew T. Chan, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Massachusetts General Hospital |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ICG Injection | Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant withdrew from the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | ICG Injection | Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Neoplastic Lesions Detected | Posted | Number | Lesions | upto 15 mins |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ICG Injection | Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew T. Chan | Massachusetts General Hospital | 617 726 3212 | achan@partners.org |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Boston |
| Massachusetts |
| 02214 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
| 0 |
| 4 |
| 0 |
| 4 |
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