Status:
COMPLETED
Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study
Lead Sponsor:
Photocure
Collaborating Sponsors:
KARL STORZ Endoscopy-America, Inc.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief 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 illumin...
Detailed Description
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 no...
Eligibility Criteria
Inclusion
- Patients with suspicion of colorectal cancer
- Written informed consent
- Data protection consent
- 18-85 years
Exclusion
- Liver cirrhosis
- Hepatitis
- Abnormal liver function
- Porphyria
- Patient non-compliance
- Coagulation disorder
- Contraindication to colonoscopy
- Pregnancy and lactation
- Participation in another study
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00285701
Start Date
July 1 2006
End Date
March 1 2008
Last Update
January 15 2010
Active Locations (1)
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1
Dept of Medicine, Munic-Hospital Pasing
Munich, Bavaria, Germany