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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of lesions

Outcome Time Frame:

An average of 15 min (during cystoscopy)

Safety Issue:

No

Principal Investigator

Alexander Karl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Urology, LMU Munich, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

PC B202/11

NCT ID:

NCT01551407

Start Date:

December 2011

Completion Date:

June 2012

Related Keywords:

  • Bladder Cancer
  • Hexvix
  • bladder cancer
  • cystoscopy
  • Patients with known or suspicion of bladder cancer
  • Urinary Bladder Neoplasms

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