Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study

Sponsor
Photocure
Study ID
NCT00285701
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Patients referred for colon inspection (colonoscopy) due to suspicion of colon polyps/cancer will receive local administration of hexaminolevulinate (HAL) prior to colon inspection. Blue light illumination will induce red fluorescence of polyps and tumours, improving detection of the polyps and tumors. Different HAL doses will be tested to find the optimal image conditions. Tolerability measurements will be performed to ensure patient safety.

Key Dates

Start date
Jul 31, 2006
Status verified
Jan 2010
Primary completion
Nov 30, 2007
Completion
Mar 31, 2008

Study Design

Enrollment
38 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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