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

NCT ID: NCT00412971

Last Updated: 2013-10-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

233 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2008-10-31

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

Conditions

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Bladder Cancer

Keywords

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Recurrence of bladder cancer Fluorescence cystoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Hexvix cystoscopy group

Group Type ACTIVE_COMPARATOR

Hexvix

Intervention Type DRUG

Single installation, TURB

White light

Standard White light cystoscopy

Group Type OTHER

Standard white light cystoscopy

Intervention Type OTHER

Interventions

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Hexvix

Single installation, TURB

Intervention Type DRUG

Standard white light cystoscopy

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Photocure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregers G Hermann, MD, DM Sci

Role: PRINCIPAL_INVESTIGATOR

Frederiksberg Hospital

Locations

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Frederiksberg Hospital

Frederiksberg, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 21414125 (View on PubMed)

Other Identifiers

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PC B304/04

Identifier Type: -

Identifier Source: org_study_id