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
  • Phase

    Phase 3
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

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.

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 Started
Sep 30
Primary Completion
May 31
Last Update
Oct 23

Drug hexaminolevulinate

Procedure biopsy

Procedure cystoscopy



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



18 and over

Performance status

Not specified

Life expectancy

Not specified


Not specified


Not specified


No gross hematuria


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


Biologic therapy

More than 3 months since prior BCG


More than 3 months since prior chemotherapy

Single prior dose of chemotherapy for prevention of seeding after resection allowed

Endocrine therapy

Not specified


Not specified


Not specified


More than 30 days since prior participation in another clinical trial
No concurrent participation in another clinical trial
No Results Posted