A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-Invasive Bladder Cancer
Recruitment status was Active, not recruiting
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Purpose
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.
The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB.
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | A Randomized, Comparative Phase III, 2-Center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-Invasive Bladder Cancer |
| Estimated Enrollment: | 164 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | September 2008 |
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.
Patients will be followed 4, 8 and 12 months after the initial TURB. This follow-up regimen is according to standard clinical practice in Denmark.
Recurrence of non-invasive bladder cancer is frequent, and this study is designed to investigate whether Hexvix assisted TURB can reduce the early recurrence compared to standard TURB
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with suspicion of non-invasive bladder cancer indicated for a transuretheral resection of the bladder
- Above 18 years
- Written informed consent obtained
Exclusion Criteria:
- Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy).
- Patient with porphyria.
- Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.
- Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
- Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter).
- Conditions associated with a risk of poor protocol compliance.
Contacts and Locations| Denmark | |
| Frederiksberg Hospital | |
| Frederiksberg, Denmark, 2000 | |
| Odense University Hospital | |
| Odense, Denmark | |
| Principal Investigator: | Gregers G Hermann, MD, DM Sci | Frederiksberg Hospital |
More Information
No publications provided by PhotoCure
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00412971 History of Changes |
| Other Study ID Numbers: | PC B304/04 |
| Study First Received: | December 18, 2006 |
| Last Updated: | September 17, 2007 |
| Health Authority: | Denmark: National Board of Health |
Keywords provided by PhotoCure:
|
Recurrence of bladder cancer Fluorescence cystoscopy |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013