A RANDOMIZED, COMPARATIVE,CONTROLLED PHASE III, MULTICENTER STUDY OF HEXVIX FLUORESCENCE CYSTOSCOPY ANDWHITE LIGHT CYSTOSCOPY IN THE DETECTION OF PAPILLARY BLADDER CANCER AND THE EARLYRECURRENCE RATE IN PATIENTS WITH BLADDER CANCER

Active, not recruiting

• Conditions: Malignant neoplasm of bladder; MedDRA version: 7.0Level: LLTClassification code 10046518

• Registration Number: EUCTR2004-002259-15-AT
• Lead Sponsor: Photocure ASA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-20
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 620

Inclusion Criteria

Male or female, aged 18 years or above, who has given written informed consent.
The patients must fulfill the following criteria:
·Patients with either more than one initial bladder tumor or recurrence within 12 months confirmed on an outpatient cystoscopy.
For the first five patients with centers with limited or no experience with Hexvix:
·Patients with an indication for a cystoscopic examination for bladder cancer.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

For all patients screened:

·Patients with known tumors in the prostatic urethra or distal urethra

·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).

·Patients who have received BCG or chemotherapy within three months prior to the initial cystoscopy/TURB, except for a single dose of chemotherapy for prevention of seeding after resection.
·Conditions associated with a risk of poor protocol compliance.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified