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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285701
• Other study ID #: PCCO101/05
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 31, 2006
• Last updated: January 14, 2010
• Start date: July 2006
• Est. completion date: March 2008

Study information

• Verified date: January 2010
• Source: Photocure
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Drug:
• hexaminolevulinate

Locations

Country	Name	City	State
Germany	Dept of Medicine, Munic-Hospital Pasing	Munic	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Photocure	KARL STORZ Endoscopy-America, Inc.

Country where clinical trial is conducted

Germany,