Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052637
Status:
COMPLETED
Last Update Posted:
2013-10-23
First Post:
2003-01-24
Brief Title:
Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer
Sponsor:
Photocure
Organization:
Photocure
Study Overview
Official Title:
An Open Comparative Within Patient Controlled Phase III Multicenter Study Of HEXVIX Fluorescence Cystoscopy And White Light Cystoscopy In the Detection Of Carcinoma In Situ In Patients With Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2013-10
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:
RATIONALE Diagnostic procedures such as cystoscopy may improve the ability to detect cancer and to determine the extent of disease
PURPOSE Diagnostic trial to compare the effectiveness of cystoscopy using hexyl 5-aminolevulinate and two light sources in detecting carcinoma in situ in patients who have bladder cancer
PURPOSE Diagnostic trial to compare the effectiveness of cystoscopy using hexyl 5-aminolevulinate and two light sources in detecting carcinoma in situ in patients who have bladder cancer
Detailed Description:
OBJECTIVES
Compare blue light fluorescent cystoscopy with reconstituted hexyl 5-aminolevulinate Hexvix vs white light cystoscopy for the detection of carcinoma in situ CIS in patients with bladder cancer
Compare the positive and false detection rates of histologically confirmed non-CIS lesions and dysplasia by these modalities in these patients
Compare the false detection rate of histologically confirmed CIS lesions by these modalities in these patients
Compare the number of tumor lesions and dysplasia detected by these modalities in these patients
Compare management of patients after evaluation with these modalities
Determine the safety of reconstituted hexyl 5-aminolevulinate Hexvix in these patients
OUTLINE This is an open-label multicenter study
Patients undergo bladder catheterization and instillation of reconstituted hexyl 5-aminolevulinate Hexvix After 60 minutes the bladder is evacuated and the patient undergoes cystoscopic examination of the bladder by white light and then blue light fluorescence Biopsies are taken of all suspicious areas seen under white andor blue light modalities and one normal-appearing area seen under both light modalities and papillary lesions are resected
Patients are followed at 7 days after procedure
PROJECTED ACCRUAL A total of 420 patients will be accrued for this study within 1 year
Compare blue light fluorescent cystoscopy with reconstituted hexyl 5-aminolevulinate Hexvix vs white light cystoscopy for the detection of carcinoma in situ CIS in patients with bladder cancer
Compare the positive and false detection rates of histologically confirmed non-CIS lesions and dysplasia by these modalities in these patients
Compare the false detection rate of histologically confirmed CIS lesions by these modalities in these patients
Compare the number of tumor lesions and dysplasia detected by these modalities in these patients
Compare management of patients after evaluation with these modalities
Determine the safety of reconstituted hexyl 5-aminolevulinate Hexvix in these patients
OUTLINE This is an open-label multicenter study
Patients undergo bladder catheterization and instillation of reconstituted hexyl 5-aminolevulinate Hexvix After 60 minutes the bladder is evacuated and the patient undergoes cystoscopic examination of the bladder by white light and then blue light fluorescence Biopsies are taken of all suspicious areas seen under white andor blue light modalities and one normal-appearing area seen under both light modalities and papillary lesions are resected
Patients are followed at 7 days after procedure
PROJECTED ACCRUAL A total of 420 patients will be accrued for this study within 1 year
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000258579 | REGISTRY | PDQ Physician Data Query | None |
| UCLA-0201058 | None | None | None |