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

Study Overview
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Brief Summary
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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
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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

Official Title
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A Randomized, Comparative Phase III, 2-center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: Hexvix
* Other: Standard white light cystoscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hexvix cystoscopy group<br> | Drug: Hexvix<br>* Single installation, TURB<br>|
| Other: White light<br>Standard White light cystoscopy | Other: Standard white light cystoscopy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | At day 0 | 
| False Positive Detection Rate Patient Level |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrence of bladder cancer, Fluorescence cystoscopy