Malignant neoplasm of bladder MedDRA version: 7.0 Level: LLT Classification code 10046518
Conditions
Interventions
Product Name: Hexvix®
Product Code: P-1206
Pharmaceutical Form: Powder for bladder irrigation
INN or Proposed INN: not available
CAS Number: 140898-91-5
Current Sponsor code: P-1206
Other descriptive
Sponsors
Photocure ASA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Co-Primary Objectives: ·To compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer. ·To compare early recurrence rate after Hexvix and white light transurethral resection (TURB) with white light TURB in patients with superficial bladder cancer. ;Secondary Objective: · Comparison of detection rate of histologically confirmed bladder lesions of Hexvix cystoscopy and white light cystoscopy. · Comparison of the proportion of false positive lesions of Hexvix cystoscopy and white light cystoscopy. · Evaluation of the clinical usefulness of Hexvix cystoscopy compared to standard cystoscopy. · Evaluation of the safety of Hexvix in patients with bladder cancer. ;Primary end point(s): Co.primary efficacy endpoints: ·The proportion of Group B subjects with histology-confirmed tumors (Ta or T1) who have at least one such tumor found by Hexvix but not by white light cystoscopy. ·Comparision of the proportions of Group A and Group B subjects who undergo TURB for a histology-confirmed Ta or T1 tumor who have a recurrence (histology-confirmed Ta or T1) found at either three, six or nine months. | — |
Countries
Austria
Outcome results
None listed