An Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon
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|ClinicalTrials.gov Identifier: NCT01344902|
Recruitment Status : Terminated (The study was stopped due to inadequate efficacy after 13 patients were evaluated.)
First Posted : April 29, 2011
Last Update Posted : October 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: hexaminolevulinate HCl||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||October 2009|
Drug: hexaminolevulinate HCl
200mg hexaminolevulinate HCl capsule 6 hours before colonoscopy
- Determine the carcinoma- and adenoma lesion true detection rate [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344902
|Klinikum München Pasing|
|Munich, Germany, 81241|