Trial Outcomes & Findings for Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract (NCT NCT01112514)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

upto 15 mins

Results posted on

2014-02-24

Participant Flow

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.

Participant milestones

Participant milestones
Measure	ICG Injection Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ICG Injection Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Indocyanine Green Fluorescent Molecular Imaging of the Gastrointestinal Tract

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ICG Injection n=4 Participants Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 9.82 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: upto 15 mins

Outcome measures

Outcome measures
Measure	ICG Injection n=3 Participants Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
Number of Neoplastic Lesions Detected	3 Lesions

Adverse Events

ICG Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew T. Chan

Massachusetts General Hospital

Phone: 617 726 3212

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place