NCT05600322

Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer

A Prospective, Comparative Within Patient Controlled, Multi-center Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Photocure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to compare Hexvix Blue light cstoscopy with standard White light cystoscopy in the detection of bladder cancer.

Detailed description

A phase III, prospective, within patient controlled, multi-center study to compare Blue light cystoscopy with Hexvix and standard White light cystoscopy in the detection of bladder cancer, to evaluate the efficacy and safety of Hexvix Blue light cystoscopy in Chinese population. Patients with suspicious or confirmed bladder cancer will participate in the trial and undergo Blue light cystoscopy with Hexvix in addition to the standard White light cystoscopy. Specific clinical questions will be asked: * What is the proportion of patients who have at least one specific kind of tumor found by Blue light cystoscopy with Hexvix but not by White light cystoscopy? * What is the proportion of patients who have at least one specific kind of lesion found by Blue light cystoscopy with Hexvix but not by White light cystoscopy? * What is the proportion of false positive lesions detected with Hexvix Blue light cystoscopy and White light cystoscopy? * What is the proportion of patients with Adverse Events (AE) during the study?

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Hexaminolevulinate Hydrochloride	Enrolled patients will be instilled with 50 mL hexaminolevulinate hydrochloride as intravesical solution (Hexvix) in the bladder for one hour at Visit 2. After bladder evacuation, the cystoscopic examinations will be performed in both white and blue light.
DEVICE	Richard Wolf Photodynamic Diagnostic Equipment (PDD) system	Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.

Timeline

• Start date: 2022-11-03
• Primary completion: 2023-07-12
• Completion: 2023-07-12
• First posted: 2022-10-31
• Last updated: 2024-10-03
• Results posted: 2024-10-03

Locations

7 sites across 1 country: China