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

Colon Cancer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01344902
• Other study ID #: PC CO201/08
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: January 14, 2010
• Last updated: October 22, 2013
• Start date: February 2009

Study information

• Verified date: October 2013
• Source: Photocure
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Drug:
• hexaminolevulinate HCl
200mg hexaminolevulinate HCl capsule 6 hours before colonoscopy

Locations

Country	Name	City	State
Germany	Klinikum München Pasing	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Photocure

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the carcinoma- and adenoma lesion true detection rate		Baseline	No