Detection of Bladder Tumors After 30 Min Instillation of Hexvix

This study has been terminated.
(slow inclusion rate)
Sponsor:
Information provided by (Responsible Party):
PhotoCure
ClinicalTrials.gov Identifier:
NCT01551407
First received: March 2, 2012
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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®.


Condition Intervention Phase
Bladder Cancer
Drug: Hexvix
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by PhotoCure:

Primary Outcome Measures:
  • Number of lesions [ Time Frame: An average of 15 min (during cystoscopy) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug related adverse events [ Time Frame: From time of drug instillation until 24 hours after cystoscopy ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: December 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Hexvix
    50 ml Hexvix liquid instilled once into the bladder for 30 minutes prior to cystoscopy
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551407

Locations
Germany
LMU Munich
Munich, Germany, D-81377
Sponsors and Collaborators
PhotoCure
Investigators
Principal Investigator: Alexander Karl, MD Department of Urology, LMU Munich, Germany
  More Information

No publications provided

Responsible Party: PhotoCure
ClinicalTrials.gov Identifier: NCT01551407     History of Changes
Other Study ID Numbers: PC B202/11
Study First Received: March 2, 2012
Last Updated: October 24, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by PhotoCure:
Hexvix
bladder cancer
cystoscopy
Patients with known or suspicion of bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014