Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285701
Status:
COMPLETED
Last Update Posted:
2010-01-15
First Post:
2006-01-31
Brief Title:
Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study
Sponsor:
Photocure
Organization:
Photocure
Study Overview
Official Title:
Early Detection of Pre-malignant and Malignant Conditions in the Colon by Means of Fluorescence Endoscopy Using Local and Oral Sensitisation With Hexaminolevulinate HAL - a Dose Finding Study
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients referred for colon inspection colonoscopy due to suspicion of colon polypscancer will receive local administration of hexaminolevulinate HAL prior to colon inspection Blue light illumination will induce red fluorescence of polyps and tumours improving detection of the polyps and tumors Different HAL doses will be tested to find the optimal image conditions Tolerability measurements will be performed to ensure patient safety
Detailed Description:
Colonoscopy is regarded as the gold standard for diagnosis of colorectal cancer The sensitivity is uncertain but proposed to be 75-95 however flat adenomas which are easily missed are often not recognised Fluorescence imaging may increase the sensitivity of standard white light colonoscopy by identifying more polyps and flat adenomas which will make the resection of adenomas more complete
In this study hexaminolevulinate HAL will be administered locally as a photosensitiser using different doses to find the optimal imaging conditions as well as making patient safety assessments
Both standard white light and blue light fluorescence inspection will be performed
In this study hexaminolevulinate HAL will be administered locally as a photosensitiser using different doses to find the optimal imaging conditions as well as making patient safety assessments
Both standard white light and blue light fluorescence inspection will be performed
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