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Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 27, 2003
Last Update Posted: October 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Cancer Institute (NCI)
Information provided by (Responsible Party):

RATIONALE: Diagnostic procedures such as cystoscopy may improve the ability to detect cancer and to determine the extent of disease.

PURPOSE: Diagnostic trial to compare the effectiveness of cystoscopy using hexyl 5-aminolevulinate and two light sources in detecting carcinoma in situ in patients who have bladder cancer.

Condition Intervention Phase
Bladder Cancer Drug: hexaminolevulinate Procedure: biopsy Procedure: cystoscopy Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Open, Comparative, Within Patient, Controlled Phase III, Multicenter Study Of HEXVIX Fluorescence Cystoscopy And White Light Cystoscopy In the Detection Of Carcinoma In Situ In Patients With Bladder Cancer

Resource links provided by NLM:

Further study details as provided by Photocure:

Study Start Date: September 2001
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Detailed Description:


  • Compare blue light fluorescent cystoscopy with reconstituted hexyl 5-aminolevulinate (Hexvix®) vs white light cystoscopy for the detection of carcinoma in situ (CIS) in patients with bladder cancer.
  • Compare the positive and false detection rates of histologically confirmed non-CIS lesions and dysplasia by these modalities in these patients.
  • Compare the false detection rate of histologically confirmed CIS lesions by these modalities in these patients.
  • Compare the number of tumor lesions and dysplasia detected by these modalities in these patients.
  • Compare management of patients after evaluation with these modalities.
  • Determine the safety of reconstituted hexyl 5-aminolevulinate (Hexvix®) in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients undergo bladder catheterization and instillation of reconstituted hexyl 5-aminolevulinate (Hexvix®). After 60 minutes the bladder is evacuated, and the patient undergoes cystoscopic examination of the bladder by white light and then blue light fluorescence. Biopsies are taken of all suspicious areas seen under white and/or blue light modalities, and one normal-appearing area seen under both light modalities, and papillary lesions are resected.

Patients are followed at 7 days after procedure.

PROJECTED ACCRUAL: A total of 420 patients will be accrued for this study within 1 year.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Indication for cystoscopy for suspected or confirmed bladder cancer
  • Meets at least one of the following criteria:

    • Multiple bladder lesions
    • Bladder lesion greater than 3 cm
    • Bladder tumor of at least stage T1
    • Grade 2 or 3 bladder tumor
    • Recurrent bladder cancer
  • No positive cytology obtained in the last 4 weeks
  • No prior G3 tumor with one set of positive random biopsies
  • No porphyria



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • No gross hematuria


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after study
  • No known allergy to reconstituted hexyl 5-aminolevulinate or a similar compound
  • No concurrent condition that would preclude study compliance


Biologic therapy

  • More than 3 months since prior BCG


  • More than 3 months since prior chemotherapy

    • Single prior dose of chemotherapy for prevention of seeding after resection allowed

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • More than 30 days since prior participation in another clinical trial
  • No concurrent participation in another clinical trial
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052637

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Peter Schulam, MD Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Photocure
ClinicalTrials.gov Identifier: NCT00052637     History of Changes
Other Study ID Numbers: PC B301/01
CDR0000258579 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: January 24, 2003
First Posted: January 27, 2003
Last Update Posted: October 23, 2013
Last Verified: October 2013

Keywords provided by Photocure:
bladder cancer
recurrent bladder cancer
stage 0 bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma in Situ
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type