An Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon
- Sponsor
- Photocure
- Study ID
- NCT01344902
- Phase
- PHASE1/PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- hexaminolevulinate HCl — DRUG200mg hexaminolevulinate HCl capsule 6 hours before colonoscopy
Study Details
The purpose of the study is to determine if it is possible to detect more pre-cancerous lesions in colon when using fluorescence technology.
Key Dates
- Start date
- Feb 28, 2009
- Status verified
- Oct 2013
- Primary completion
- Oct 31, 2009
Study Design
- Enrollment
- 13 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Hexaminolevulinate
Primary Outcome Measure
Determine the carcinoma- and adenoma lesion true detection rate [ Time Frame: Baseline ]
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