Overview
Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
PhotocureCollaborator:
National Cancer Institute (NCI)
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