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Hexarelin

Examorelin, HEX

Quick Stats
Studies 233
Trials 61
Completed PHASE3 INTERVENTIONAL NCT05600322

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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?

Interventions

Name: Hexaminolevulinate Hydrochloride
Type: DRUG
Description: 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.
Name: Richard Wolf Photodynamic Diagnostic Equipment (PDD) system
Type: DEVICE
Description: Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.

Primary Outcomes

Measure: Number of Patients With Histology-confirmed Lesions (Ta, T1, or CIS) Who Have at Least One Such Lesion Found by Hexvix Blue Light Cystoscopy But Not by White Light Cystoscopy.
TimeFrame: 1 day (At time of cystoscopy examination)
Description: In the subsection of patients with histology-confirmed lesions (Ta, T1, or CIS) , the number of patients who have at least one such lesion found by Hexvix blue light cystoscopy but not by white light cystoscopy is measured.

Trial Information

NCT ID

NCT05600322

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Photocure

Last Updated

December 15, 2025