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A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-Invasive Bladder Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: PhotoCure
Information provided by: PhotoCure
ClinicalTrials.gov Identifier: NCT00412971
  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.


Condition Phase
Bladder Cancer
Phase III

Genetics Home Reference related topics: bladder cancer
MedlinePlus related topics: Bladder Cancer Cancer
Drug Information available for: Hexyl 5-aminolevulinate
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: A Randomized, Comparative Phase III, 2-Center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-Invasive Bladder Cancer

Further study details as provided by PhotoCure:

Estimated Enrollment: 164
Study Start Date: April 2005
Estimated Study Completion Date: September 2008
Detailed Description:

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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412971

Locations
Denmark
Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Odense University Hospital
Odense, Denmark
Sponsors and Collaborators
PhotoCure
Investigators
Principal Investigator: Gregers G Hermann, MD, DM Sci Frederiksberg Hospital
  More Information

Study ID Numbers: PC B304/04
Study First Received: December 18, 2006
Last Updated: September 17, 2007
ClinicalTrials.gov Identifier: NCT00412971  
Health Authority: Denmark: National Board of Health

Keywords provided by PhotoCure:
Recurrence of bladder cancer
Fluorescence cystoscopy

Study placed in the following topic categories:
Cystocele
Urologic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Urologic Neoplasms
Urinary tract neoplasm
Recurrence
Bladder neoplasm

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009