Ignite Creation Date:
2024-05-06 @ 12:21 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01551407
Status:
TERMINATED
Last Update Posted:
2012-10-25
First Post:
2012-03-02
Brief Title:
Detection of Bladder Tumors After 30 Min Instillation of Hexvix
Sponsor:
Photocure
Organization:
Photocure
Study Overview
Official Title:
Open Prospective Within Patient Phase IIa Study of Hexvix Flexible Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer After 30 Minutes Instillation of Hexvix in Patients With Known or Suspicion of Bladder Cancer
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow inclusion rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the study is to compare Hexvix flexible cystoscopy and white light flexible cystoscopy in the detection of histological confirmed bladder tumor lesions defined as dysplasia CIS Ta T1 and T2 after 30 minutes intravesical instillation of Hexvix
Detailed Description:
This study is an open prospective within patient controlled multi-center Phase IIa study in patients with bladder cancer
The bladder of all patients will be instilled with 50 mL Hexvix 8 mM solution and evacuated after 30 minutes After bladder evacuation the bladder will be examined under white light cystoscopy using the Karl Storz flexible videocystoscope Tumors visible under white light will be mapped Then the bladder is evaluated with blue light and lesions seen by blue light will be mapped Biopsies of all visible tumors will be taken using both white and blue light prior to resection of all lesions
The bladder of all patients will be instilled with 50 mL Hexvix 8 mM solution and evacuated after 30 minutes After bladder evacuation the bladder will be examined under white light cystoscopy using the Karl Storz flexible videocystoscope Tumors visible under white light will be mapped Then the bladder is evaluated with blue light and lesions seen by blue light will be mapped Biopsies of all visible tumors will be taken using both white and blue light prior to resection of all lesions
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