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

NCT00052637 | Completed Phase 3

• 3 other identifiers: PC B301/01UCLA-0201058CDR0000258579
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Keywords

bladder cancer; recurrent bladder cancer; stage 0 bladder cancer

Interventions

hexaminolevulinate DRUG

biopsy PROCEDURE

cystoscopy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Photocure: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

5-aminolevulinic acid hexyl ester; Biopsy; Cystoscopy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Endoscopy; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Peter Schulam, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2003
• First Posted: January 27, 2003
• Study Start: September 1, 2001
• Primary Completion: May 1, 2002
• Last Updated: October 23, 2013

Record last verified: 2013-10

Locations

US (1)