NCT01551407

Detection of Bladder Tumors After 30 Min Instillation of Hexvix

Open Prospective Within Patient, Phase IIa Study of Hexvix Flexible Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer After 30 Minutes Instillation of Hexvix in Patients With Known or Suspicion of Bladder Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Photocure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to compare Hexvix® flexible cystoscopy and white light flexible cystoscopy in the detection of histological confirmed bladder tumor lesions defined as dysplasia; CIS; Ta; T1; and ≥ T2 after 30 minutes intravesical instillation of Hexvix®.

Detailed description

This study is an open, prospective, within patient, controlled, multi-center, Phase IIa study in patients with bladder cancer. The bladder of all patients will be instilled with 50 mL Hexvix® 8 mM solution and evacuated after 30 minutes. After bladder evacuation, the bladder will be examined under white light cystoscopy using the Karl Storz flexible videocystoscope. Tumors visible under white light will be mapped. Then the bladder is evaluated with blue light and lesions seen by blue light will be mapped. Biopsies of all visible tumors will be taken using both white and blue light prior to resection of all lesions.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Hexvix	50 ml Hexvix liquid instilled once into the bladder for 30 minutes prior to cystoscopy

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-03-12
• Last updated: 2012-10-25

Locations

1 site across 1 country: Germany