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
18 Years
N/A
Both
Bladder Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Diagnostic
Principal Investigator
Peter Schulam, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000258579
NCT ID:
NCT00052637
Start Date:
September 2002
Completion Date:
Related Keywords:
- Bladder Cancer
- bladder cancer
- recurrent bladder cancer
- stage 0 bladder cancer
- Urinary Bladder Neoplasms
- Carcinoma
- Carcinoma in Situ
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
