Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||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|
|Study Start Date:||July 2006|
|Study Completion Date:||March 2008|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
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 safety assessments.
Both standard white light and blue light (fluorescence) inspection will be performed.
|Dept of Medicine, Munic-Hospital Pasing|
|Munic, Bayern, Germany|
|Principal Investigator:||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|