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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00412971
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : October 11, 2013
Last Update Posted : October 11, 2013
Sponsor:
Information provided by (Responsible Party):
Photocure

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Bladder Cancer Drug: Hexvix Other: Standard white light cystoscopy Phase 3

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2005
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Hexvix cystoscopy group Drug: Hexvix
Single installation, TURB
White light
Standard White light cystoscopy
 Other: Standard white light cystoscopy


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year. [ Time Frame: 1 year ]
    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 :
  1. 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 ]
  2. False Positive Detection Rate Patient Level [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412971


Locations
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Denmark
Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Odense University Hospital
Odense, Denmark
Sponsors and Collaborators
Photocure
Investigators
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Principal Investigator: Gregers G Hermann, MD, DM Sci Frederiksberg Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Photocure
ClinicalTrials.gov Identifier: NCT00412971    
Other Study ID Numbers: PC B304/04
First Posted: December 19, 2006    Key Record Dates
Results First Posted: October 11, 2013
Last Update Posted: October 11, 2013
Last Verified: August 2013
Keywords provided by Photocure:
Recurrence of bladder cancer
Fluorescence cystoscopy
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases