Back to resultsRecurrence of Bladder Cancer After Transurethral Resection With Hexvix
Primary Purpose
Bladder Cancer
Status
Withdrawn
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
hexaminolevulinate
Sponsored by
About this trial
This is an interventional diagnostic trial for Bladder Cancer
Eligibility Criteria
Inclusion Criteria:
- The subject is not of childbearing potential and signed informed consent.
- Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy.
Exclusion Criteria:
- The subject was previously included in this study.
- The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS).
- The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence.
- The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract.
- The subject has gross haematuria.
- The subject has a history of porphyria.
Sites / Locations
- GE Healthcare Medical Diagnostics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
B
A
Arm Description
One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.
Multiple instillations of mitomycin C after transurethral resection in white light alone.
Outcomes
Primary Outcome Measures
Rate of bladder cancer recurrence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00785694
Brief Title
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix
Official Title
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Rejected ethics approval in UK and Holland
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomised, comparative, multicentre study to determine if the early recurrence rate of intermediate-risk bladder cancer is similar in subjects treated with multiple instillations of mitomycin C after resection conducted under white light cystoscopy (group A) and subjects treated with 1 instillation of mitomycin C after resection conducted under white light and blue light cystoscopy (group B).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B
Arm Type
Experimental
Arm Description
One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.
Arm Title
A
Arm Type
No Intervention
Arm Description
Multiple instillations of mitomycin C after transurethral resection in white light alone.
Intervention Type
Drug
Intervention Name(s)
hexaminolevulinate
Other Intervention Name(s)
Hexvix
Intervention Description
Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.
Primary Outcome Measure Information:
Title
Rate of bladder cancer recurrence
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject is not of childbearing potential and signed informed consent.
Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy.
Exclusion Criteria:
The subject was previously included in this study.
The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS).
The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence.
The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract.
The subject has gross haematuria.
The subject has a history of porphyria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Antonini
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GE Healthcare Medical Diagnostics
City
Velizy Cedex
State/Province
Morane Saulnier
ZIP/Postal Code
78457
Country
France
12. IPD Sharing Statement
Learn more about this trial
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix
We'll reach out to this number within 24 hrs