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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

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ClinicalTrials.gov Identifier: NCT01344902
Recruitment Status : Terminated (The study was stopped due to inadequate efficacy after 13 patients were evaluated.)
First Posted : April 29, 2011
Last Update Posted : October 23, 2013
Sponsor:
Information provided by (Responsible Party):
Photocure

Brief Summary:
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 or disease Intervention/treatment Phase
Colon Cancer Drug: hexaminolevulinate HCl Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : February 2009
Actual Primary Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hexaminolevulinate Drug: hexaminolevulinate HCl
200mg hexaminolevulinate HCl capsule 6 hours before colonoscopy




Primary Outcome Measures :
  1. Determine the carcinoma- and adenoma lesion true detection rate [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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

Publications of Results:
Responsible Party: Photocure
ClinicalTrials.gov Identifier: NCT01344902     History of Changes
Other Study ID Numbers: PC CO201/08
First Posted: April 29, 2011    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents