Ignite Creation Date:
2024-05-05 @ 11:30 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01344902
Status:
TERMINATED
Last Update Posted:
2013-10-23
First Post:
2010-01-14
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
Sponsor:
Photocure
Organization:
Photocure
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped due to inadequate efficacy after 13 patients were evaluated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None