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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:
ClinicalTrials.gov Identifier:
NCT01344902
First Posted: April 29, 2011
Last Update Posted: October 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Photocure
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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
First Submitted: January 14, 2010
First Posted: April 29, 2011
Last Update Posted: October 23, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents