Back to resultsA Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Hexvix
Standard white light cystoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Bladder Cancer focused on measuring Recurrence of bladder cancer, Fluorescence cystoscopy
Eligibility 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.
Sites / Locations
- Frederiksberg Hospital
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Hexvix cystoscopy group
White light
Arm Description
Standard White light cystoscopy
Outcomes
Primary Outcome Measures
Proportion of Patients With Histologically Confirmed Recurrence Within One 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
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.
False Positive Detection Rate Patient Level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00412971
Brief Title
A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Photocure
4. Oversight
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Recurrence of bladder cancer, Fluorescence cystoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
233 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hexvix cystoscopy group
Arm Type
Active Comparator
Arm Title
White light
Arm Type
Other
Arm Description
Standard White light cystoscopy
Intervention Type
Drug
Intervention Name(s)
Hexvix
Intervention Description
Single installation, TURB
Intervention Type
Other
Intervention Name(s)
Standard white light cystoscopy
Primary Outcome Measure Information:
Title
Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Title
False Positive Detection Rate Patient Level
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregers G Hermann, MD, DM Sci
Organizational Affiliation
Frederiksberg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
21414125
Citation
Hermann GG, Mogensen K, Carlsson S, Marcussen N, Duun S. Fluorescence-guided transurethral resection of bladder tumours reduces bladder tumour recurrence due to less residual tumour tissue in Ta/T1 patients: a randomized two-centre study. BJU Int. 2011 Oct;108(8 Pt 2):E297-303. doi: 10.1111/j.1464-410X.2011.10090.x. Epub 2011 Mar 17.
Results Reference
derived
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A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
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