Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233402
Status:
COMPLETED
Last Update Posted:
2013-10-11
First Post:
2005-10-04
Brief Title:
Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
Sponsor:
Photocure
Organization:
Photocure
Study Overview
Official Title:
A Randomized Comparative Controlled Phase III Multicenter Study of Hexvix Fluorescence Cystoscopy and White Light Cystoscopy in the Detection Of Papillary Bladder Cancer and the Early Recurrence Rate in Patients With Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2013-08
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:
The purpose of this study is to document the additional detection of papillary bladder cancer and the reduced early recurrence due to the improved detection and resection of these tumors after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder cancer
Detailed Description:
In superficial bladder cancer macroscopic tumors including non-invasive papillary tumors Ta in the bladder are relatively easy to visualize by cystoscopic examination under white light However dysplasia carcinoma in situ CIS or small exophytic tumors are easily overlooked These lesions are predictive of recurrence and progression of disease and the identification of these lesions is a crucial factor for the prognosis of the patient The present situation with 50-75 recurrence rate show the inadequacy of white light cystoscopy for detection and resection of the lesions
A better detection of papillary bladder cancer and early detection of CIS lesions will provide the patient with a more complete TURB a more optimal pharmacological treatment when needed may reduce the need for follow up cystoscopies and hopefully result in a better prognosis for the patient
The aim of the present study is to compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer and to compare early recurrence rate after Hexvix and white light transurethral resection TURB with white light TURB in patients with superficial bladder cancer
A better detection of papillary bladder cancer and early detection of CIS lesions will provide the patient with a more complete TURB a more optimal pharmacological treatment when needed may reduce the need for follow up cystoscopies and hopefully result in a better prognosis for the patient
The aim of the present study is to compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer and to compare early recurrence rate after Hexvix and white light transurethral resection TURB with white light TURB in patients with superficial bladder cancer
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