Detection of Bladder Tumors After 30 Min Instillation of Hexvix
Detection of Bladder Tumors After 30 Min Instillation of Hexvix
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