Education and Training
Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
The purpose of this study is to document the additional detection of papillary bladder cancer and the reduced early recurrence due to the improved detection and resection of these tumors after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder cancer.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Hexvix
- procedure: Standard white light cystoscopy
Eligibility
Inclusion Criteria:
The patients should be indicated for a cystoscopic examination for suspected or verified
papillary bladder cancer and fulfill one or more of the following criteria:
- Patients with more than one initial bladder tumor confirmed on an outpatient
cystoscopy.
- Patients having recurrence within 12 months confirmed on an outpatient cystoscopy
- Patients with more than one papillary lesion at recurrence independently of the time
of the recurrence confirmed on an outpatient cystoscopy
Exclusion Criteria:
- Patients with known tumors in the prostatic urethra or distal urethra
- Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting
in marked amounts of blood in the urine, which may interfere with fluorescence
cystoscopy. Where the bleed is light, the patient should not be excluded if in the
investigator's opinion, rinsing during cystoscopy will alleviate the possible
interference with fluorescence cystoscopy).
- Patient with porphyria.
- Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.
- Participation in other clinical studies with investigational drugs either concurrently
or within the last 30 days.
- Pregnant or breast-feeding (all women of child-bearing potential must document a
negative serum or urine pregnancy test at screening and use the contraceptive pill or
intrauterine device (IUD) during the treatments and for at least one month
thereafter).
- Patients who have received BCG or chemotherapy within three months prior to the
initial cystoscopy/TURB, except for a single dose of chemotherapy for prevention of
seeding after resection.
- Conditions associated with a risk of poor protocol compliance.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ruth Lira
6507231367
Not Recruiting