Early Detection of Pre-malignant and Malignant Conditions in the Colon by Means of Fluorescence Endoscopy Using Local and Oral Sensitisation With Hexaminolevulinate (HAL) - a Dose Finding Study
Colonoscopy is regarded as the "gold standard" for diagnosis of colorectal cancer. The
sensitivity is uncertain but proposed to be (75-95%), however flat adenomas which are easily
missed, are often not recognised. Fluorescence imaging may increase the sensitivity of
standard white light colonoscopy by identifying more polyps and flat adenomas which will
make the resection of adenomas more complete.
In this study hexaminolevulinate (HAL) will be administered locally as a photosensitiser,
using different doses to find the optimal imaging conditions as well as making patient
Both standard white light and blue light (fluorescence) inspection will be performed.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Brigitte Mayinger, MD, PhD
Endlicher E, et al. Hexaminolevulinate-induced fluorescence endoscopy in patients with rectal adenoma and cancer: a pilot study. Gastrointestinal Endoscopy 2004;60:449-454
Germany: Federal Institute for Drugs and Medical Devices