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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


Phase 1/Phase 2
18 Years
85 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Brigitte Mayinger, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Endlicher E, et al. Hexaminolevulinate-induced fluorescence endoscopy in patients with rectal adenoma and cancer: a pilot study. Gastrointestinal Endoscopy 2004;60:449-454

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

PCCO101/05

NCT ID:

NCT00285701

Start Date:

July 2006

Completion Date:

March 2008

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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