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Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy

Phase 3
Waitlist Available
Led By H Barton Grossman
Research Sponsored by Photocure
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

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.

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard White Light and Hexvix Fluorescence CystoscopyExperimental Treatment2 Interventions
Group II: Standard White Light CystoscopyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard white light cystoscopy
2005
Completed Phase 3
~1030
Hexaminolevulinate
FDA approved

Find a Location

Who is running the clinical trial?

PhotocureLead Sponsor
24 Previous Clinical Trials
26,540 Total Patients Enrolled
H Barton GrossmanPrincipal InvestigatorThe University of Texas, MD Anderson Cancer Center, Department of Urology
~38 spots leftby Dec 2025
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