Detection of Bladder Tumors After 30 Min Instillation of Hexvix

Open Prospective Within Patient, Phase IIa Study of Hexvix Flexible Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer After 30 Minutes Instillation of Hexvix in Patients With Known or Suspicion of Bladder Cancer

The objective of the study is to compare Hexvix® flexible cystoscopy and white light flexible cystoscopy in the detection of histological confirmed bladder tumor lesions defined as dysplasia; CIS; Ta; T1; and ≥ T2 after 30 minutes intravesical instillation of Hexvix®.

This study is an open, prospective, within patient, controlled, multi-center, Phase IIa study in patients with bladder cancer.

The bladder of all patients will be instilled with 50 mL Hexvix® 8 mM solution and evacuated after 30 minutes. After bladder evacuation, the bladder will be examined under white light cystoscopy using the Karl Storz flexible videocystoscope. Tumors visible under white light will be mapped. Then the bladder is evaluated with blue light and lesions seen by blue light will be mapped. Biopsies of all visible tumors will be taken using both white and blue light prior to resection of all lesions.

Inclusion Criteria:

The patients should be indicated for a transurethral resection of the bladder (TURB) based on an outpatient cystoscopy and fulfil the following inclusion criteria:

• Patients with multiple bladder tumors, defined as ≥2 lesions, based on an outpatient cystoscopy.
• Patients with known urinary urge symptoms or patients who have problems or pain holding back the urine for a time longer than 30 minutes.
• Age 18 years or above

Exclusion Criteria:

• Patients with known tumors in the prostatic urethra or distal urethra
• Gross haematuria. (Note: Gross haematuria 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.
• Hypersensitivity to the active substance or to any of the excipients of the solvent
• Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
• Women of child-bearing potential meaning that only post-menopausal women, women who had their ovaries removed, and women who are otherwise physically unable to bear children can be included.
• Patients who have received BCG or chemotherapy within three months prior to study inclusion.
• Conditions associated with a risk of poor protocol compliance.
• Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the clinical study.
• Patients unlikely to comply with protocol