A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhotoCure
ClinicalTrials.gov Identifier:
NCT00412971
First received: December 18, 2006
Last updated: August 5, 2013
Last verified: August 2013
  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 Intervention Phase
Bladder Cancer
Drug: Hexvix
Other: Standard white light cystoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized, Comparative Phase III, 2-center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer

Resource links provided by NLM:


Further study details as provided by PhotoCure:

Primary Outcome Measures:
  • Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour.


Secondary Outcome Measures:
  • Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy. [ Time Frame: At day 0 ] [ Designated as safety issue: No ]
  • False Positive Detection Rate Patient Level [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 233
Study Start Date: April 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hexvix cystoscopy group Drug: Hexvix
Single installation, TURB
White light
Standard White light cystoscopy
Other: Standard white light cystoscopy

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by PhotoCure

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PhotoCure
ClinicalTrials.gov Identifier: NCT00412971     History of Changes
Other Study ID Numbers: PC B304/04
Study First Received: December 18, 2006
Results First Received: August 5, 2013
Last Updated: August 5, 2013
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 October 01, 2014