An Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon
The purpose of the study is to determine if it is possible to detect more pre-cancerous lesions in colon when using fluorescence technology.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
- Determine the carcinoma- and adenoma lesion true detection rate [ Time Frame: Baseline ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Drug: hexaminolevulinate HCl
200mg hexaminolevulinate HCl capsule 6 hours before colonoscopy
Carcinoma of the lower GI-tract is among the leading malignancies in the western world causing a substantial morbidity, mortality and consequently a large burden to the health care system in the diagnosis, treatment and follow-up of these patients.
The primary objectives of this study is to determine carcinoma- and adenoma lesion true detection rate of HAL fluorescence colonoscopy in patients with known or strong suspicion of neoplasia in the colon. The secondary objective and endpoints are to determine carcinoma- and adenoma lesion false detection rate of HAL fluorescence colonoscopy, to compare carcinoma- and adenoma lesion true detection rates and the false detection rates of fluorescence with standard colonoscopy and to characterize the safety profile of HAL fluorescence colonoscopy.