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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Photocure
• Collaborator: KARL STORZ Endoscopy-America, Inc.
• Treatments: Aminolevulinic Acid

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