Back to resultsAn Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon
Primary Purpose
Colon Cancer
Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
hexaminolevulinate HCl
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Cancer
Eligibility 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
Sites / Locations
- Klinikum München Pasing
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hexaminolevulinate
Arm Description
Outcomes
Primary Outcome Measures
Determine the carcinoma- and adenoma lesion true detection rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01344902
Brief Title
An Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to inadequate efficacy after 13 patients were evaluated.
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Photocure
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hexaminolevulinate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
hexaminolevulinate HCl
Intervention Description
200mg hexaminolevulinate HCl capsule 6 hours before colonoscopy
Primary Outcome Measure Information:
Title
Determine the carcinoma- and adenoma lesion true detection rate
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Klinikum München Pasing
City
Munich
ZIP/Postal Code
81241
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
18197583
Citation
Mayinger B, Neumann F, Kastner C, Degitz K, Hahn EG, Schwab D. Early detection of premalignant conditions in the colon by fluorescence endoscopy using local sensitization with hexaminolevulinate. Endoscopy. 2008 Feb;40(2):106-9. doi: 10.1055/s-2007-967019. Epub 2008 Jan 16.
Results Reference
result
Learn more about this trial
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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