- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00785694
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix
April 23, 2015 updated by: GE Healthcare
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).
Study Overview
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Morane Saulnier
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Velizy Cedex, Morane Saulnier, France, 78457
- GE Healthcare Medical Diagnostics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: B
One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.
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Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.
Other Names:
|
NO_INTERVENTION: A
Multiple instillations of mitomycin C after transurethral resection in white light alone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of bladder cancer recurrence
Time Frame: 12 Months
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (ACTUAL)
August 1, 2011
Study Completion (ACTUAL)
August 1, 2011
Study Registration Dates
First Submitted
November 4, 2008
First Submitted That Met QC Criteria
November 4, 2008
First Posted (ESTIMATE)
November 5, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
April 24, 2015
Last Update Submitted That Met QC Criteria
April 23, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GE-196-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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