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

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ClinicalTrials.gov Identifier: NCT00285701
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : January 15, 2010
Sponsor:
Collaborator:
KARL STORZ Endoscopy-America, Inc.
Information provided by:
Photocure

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 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 or disease Intervention/treatment Phase
Colorectal Cancer Drug: hexaminolevulinate Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2006
Primary Completion Date : November 2007
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources





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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00285701     History of Changes
Other Study ID Numbers: PCCO101/05
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010

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
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents