Trial | NCT00285701  Report issue

Title

Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study
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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    38
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.
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.
Study Started
Jul 31
2006
Primary Completion
Nov 30
2007
Study Completion
Mar 31
2008
Last Update
Jan 15
2010
Estimate

Drug hexaminolevulinate

Criteria 

Inclusion Criteria:

Patients with suspicion of colorectal cancer
Written informed consent
Data protection consent
18-85 years

Exclusion Criteria:

Liver cirrhosis
Hepatitis
Abnormal liver function
Porphyria
Patient non-compliance
Coagulation disorder
Contraindication to colonoscopy
Pregnancy and lactation
Participation in another study
No Results Posted