An Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon

This study has been terminated.
(The study was stopped due to inadequate efficacy after 13 patients were evaluated.)
Sponsor:
Information provided by (Responsible Party):
PhotoCure
ClinicalTrials.gov Identifier:
NCT01344902
First received: January 14, 2010
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

The purpose of the study is to determine if it is possible to detect more pre-cancerous lesions in colon when using fluorescence technology.


Condition Intervention Phase
Colon Cancer
Drug: hexaminolevulinate HCl
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by PhotoCure:

Primary Outcome Measures:
  • Determine the carcinoma- and adenoma lesion true detection rate [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hexaminolevulinate Drug: hexaminolevulinate HCl
200mg hexaminolevulinate HCl capsule 6 hours before colonoscopy

Detailed Description:

Carcinoma of the lower GI-tract is among the leading malignancies in the western world causing a substantial morbidity, mortality and consequently a large burden to the health care system in the diagnosis, treatment and follow-up of these patients.

The primary objectives of this study is to determine carcinoma- and adenoma lesion true detection rate of HAL fluorescence colonoscopy in patients with known or strong suspicion of neoplasia in the colon. The secondary objective and endpoints are to determine carcinoma- and adenoma lesion false detection rate of HAL fluorescence colonoscopy, to compare carcinoma- and adenoma lesion true detection rates and the false detection rates of fluorescence with standard colonoscopy and to characterize the safety profile of HAL fluorescence colonoscopy.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and Male subjects with known or strong suspicion iof adenoma or carcinoma of the colon after screening of follow-up colonoscopy
  • Female and male patients with verified neoplastic lesions

Exclusion Criteria:

  • Known or strong suspected porphyria
  • Contraindications to colonoscopy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344902

Locations
Germany
Klinikum München Pasing
Munich, Germany, 81241
Sponsors and Collaborators
PhotoCure
  More Information

Publications:
Responsible Party: PhotoCure
ClinicalTrials.gov Identifier: NCT01344902     History of Changes
Other Study ID Numbers: PC CO201/08
Study First Received: January 14, 2010
Last Updated: October 22, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 23, 2014