Clinical trial · Interventional
Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer
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
NCT00052637CI-TRIAL-00012438completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| cystoscopy | Procedure | — | UNRESOLVED |
| hexaminolevulinate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.