Spots Global Cancer Trial Database for Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer
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Trial Identification
Brief Title: Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer
Official Title: A Prospective, Comparative Within Patient Controlled, Multi-center Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer
Study ID: NCT05600322
Conditions
Study Description
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?
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
Peking University Third Hospital, Beijing, Beijing, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangzhou Province, China
Wuhan University People's Hospital, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China
The Second Hospital of Tianjin Medical University, Tianjin, Tianjin City, China
Contact Details
Name: Li Han Zhong, BMed
Affiliation: Peking Union Medical College Hospital
Role: PRINCIPAL_INVESTIGATOR
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