CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 789 enrolled
Drug / intervention
Hexvix +1 moredrug
Likely dose
Hexvix single instillation via transurethral resection of the bladderAI-extracted
Key inclusion· 3
  • ✓Patients with more than one initial bladder tumor confirmed on outpatient cystoscopy
  • ✓Patients with recurrence within 12 months confirmed on outpatient cystoscopy
  • ✓Patients with more than one papillary lesion at recurrence (any time frame) confirmed on outpatient cystoscopy
Key exclusion· 7
  • ✕Known tumors in the prostatic urethra or distal urethra
  • ✕Gross hematuria (heavy bladder bleed with marked amounts of blood in urine that may interfere with fluorescence cystoscopy)
  • ✕Patient with porphyria
  • ✕Known allergy to hexyl aminolevulinate hydrochloride or similar compound

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00233402
NCT00233402Phase 3Completed
CompareCT.gov

A Randomized, Comparative, Controlled Phase III, Multicenter Study of Hexvix Fluorescence Cystoscopy and White Light Cystoscopy in the Detection Of Papillary Bladder Cancer and the Early Recurrence Rate in Patients With Bladder Cancer

Photocure·interventional·Posted Oct 5, 2005·Updated Oct 11, 2013

In Brief

A Phase 3 clinical trial evaluating Hexvix and Standard white light cystoscopy for Bladder Cancer. Completed, enrolled 789 participants across 25 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesAustria, Canada, Germany, Netherlands, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 5, 2005
Enrollment StartJan 1, 2005
Primary CompletionJul 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.7 years ago

Interventions

Hexvixdrug

Single Instillation, Transurethral Resection of the Bladder

Standard white light cystoscopyprocedure