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

October 22, 2013 updated by: Photocure

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Jonsson Comprehensive Cancer Center, UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Photocure

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Peter Schulam, MD, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (ACTUAL)

May 1, 2002

Study Registration Dates

First Submitted

January 24, 2003

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

October 23, 2013

Last Update Submitted That Met QC Criteria

October 22, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC B301/01
  • UCLA-0201058
  • CDR0000258579 (REGISTRY: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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