A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: Hexaminolevulinate hydrochloride; KARL STORZ D-Light C PDD Flexible Videoscope System
Intervention description: Instillation in bladder; Cystoscopy procedure
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: This is a prospective, open, comparative, within-patient controlled Phase 3 multicenter study in patients with bladder cancer. There is a maximum of three study visits for an enrolled patient:
Visit 1: Screening visit Visit 2: Surveillance cystoscopy in white light (WL) followed by blue light (BL) Visit 3: Operating room (OR) cystoscopy in WL followed by BL for patients with suspicion of recurrence after surveillance cystoscopy.
Cystoscopy in WL followed by BL is performed in all patients after Cysview instillation. Only patients with suspicious lesions at Visit 2 continue to a second cystoscopy in WL followed by BL at Visit 3.
Masking: None (Open Label)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-muscle invasive bladder cancer; NMIBC; Cysview

Summary:

      The purpose of this study is to investigate if blue light cystoscopy with Cysview improves
      detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the
      KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if
      Cysview and blue light is safe and effective when used repeatedly.
    

Eligibility criteria:

        1. Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients must be
             included only at the first surveillance cystoscopy after a histologically confirmed
             tumor. The histologically confirmed tumor could either be from a TURB or from a
             surveillance cystoscopy where a biopsy was taken and a tumor was confirmed by
             histology)

          2. History of one or more of the following:

               -  Multiple tumors

               -  Recurrent tumors

               -  High grade tumor(s)

        Exclusion Criteria:

          1. Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed
             resulting in significant amounts of blood in the urine, which may visually limit
             cystoscopy. Where the haematuria is light, the patient should not be excluded, if in
             the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will
             alleviate the haematuria limitations to cystoscopy)

          2. Patients who cannot undergo in-office or operating room cystoscopy (Note: Training
             patients are eligible even if they cannot undergo operating room cystoscopy)

          3. Patients who have received Bacillus Calmette-Guérin (BCG) immunotherapy or
             intravesical chemotherapy within the past 6 weeks prior to the procedure

          4. Porphyria

          5. Known allergy to hexaminolevulinate hydrochloride or a similar compound

          6. Pregnancy or breast-feeding (all women of child-bearing potential must document a
             negative urine pregnancy test before study inclusion and use adequate contraception
             during the study

          7. Participation in other clinical studies with investigational drugs either concurrently
             or within the last 30 days

          8. 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

          9. Patients that the investigator believes are unlikely to comply with the protocol, e.g.
             mental condition rendering the patient unable to understand the nature, scope, and
             possible consequences of participating in the clinical study, uncooperative attitude
             or unlikelihood of completing the study