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

This study has been completed.
Sponsor:
Collaborator:
KARL STORZ ENDOSCOPY-AMERICA, Inc.
Information provided by:
PhotoCure
ClinicalTrials.gov Identifier:
NCT00285701
First received: January 31, 2006
Last updated: January 14, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
 Drug: hexaminolevulinate
 Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by PhotoCure:

Enrollment: 38
Study Start Date: July 2006
Study Completion Date: March 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285701

Locations
Germany
Dept of Medicine, Munic-Hospital Pasing
Munic, Bayern, Germany
Sponsors and Collaborators
PhotoCure
KARL STORZ ENDOSCOPY-AMERICA, Inc.
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00285701     History of Changes
Other Study ID Numbers: PCCO101/05
Study First Received: January 31, 2006
Last Updated: January 14, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013