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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
PhotoCure
ClinicalTrials.gov Identifier:
NCT00052637
First received: January 24, 2003
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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: 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:

OBJECTIVES:

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • No gross hematuria

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 3 months since prior BCG

Chemotherapy

  • More than 3 months since prior chemotherapy

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

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 30 days since prior participation in another clinical trial
  • No concurrent participation in another clinical trial
  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: NCT00052637

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
PhotoCure
Investigators
Principal Investigator: Peter Schulam, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: PhotoCure
ClinicalTrials.gov Identifier: NCT00052637     History of Changes
Other Study ID Numbers: PC B301/01, UCLA-0201058, CDR0000258579
Study First Received: January 24, 2003
Last Updated: October 22, 2013
Health Authority: United States: Federal Government

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
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 01, 2014