Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT05600322|
Recruitment Status : Recruiting
First Posted : October 31, 2022
Last Update Posted : February 9, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Hexaminolevulinate Hydrochloride Device: Richard Wolf Photodynamic Diagnostic Equipment (PDD) system||Phase 3|
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?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||380 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
This is a prospective, comparative, within patient controlled, multi-center study of Hexvix Blue light cystoscopy and standard White light cystoscopy in the detection of bladder cancer. Patients with suspicious or confirmed bladder cancer will be enrolled and there will be a maximum of three regular study visits for each patient. Visit 1 is a screening visit, Visit 2 is the cystoscopic examinations and Visit 3 is the safety follow-up.
At Visit 2, enrolled patients will be instilled with 50 mL Hexvix solution in the bladder for one hour. After bladder evacuation, the inspection of the bladder and mapping of lesions seen under White light will be done. Secondly, inspection of the bladder and mapping of lesions seen under Blue light will be done. The Richard Wold PDD system (System Blue) will be used. Lesions detected will be resected or biopsied and sent to the local and central pathologists for analysis.
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 4, 2022|
|Estimated Primary Completion Date :||August 31, 2023|
|Estimated Study Completion Date :||August 31, 2023|
Experimental: Hexvix Blue light cystoscopy
In this study, enrolled patients will undergo standard White light cystoscopy and Blue light cystoscopy following Hexvix administration. Lesions detected during the cystoscopies will be resected or biopsied.
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.
Other Name: Hexvix
Device: Richard Wolf Photodynamic Diagnostic Equipment (PDD) system
Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.
Other Name: System Blue
- Proportion 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. [ Time Frame: 1 day (At time of cystoscopy examination) ]
- Proportion of subjects with at least one additional CIS lesion detected with Hexvix blue light cystoscopy but not with white light cystoscopy. [ Time Frame: 1 day (At time of cystoscopy examination) ]
- The lesion detection rate of Hexvix blue light cystoscopy and white light cystoscopy for following lesion types (PUNLMP, CIS, Ta, T1, T2-T4). [ Time Frame: 1 day (At time of cystoscopy examination) ]
- The proportion of false positive lesions detected with Hexvix blue light cystoscopy and white light cystoscopy. [ Time Frame: 1 day (At time of cystoscopy examination) ]
- The proportion of patients with AEs during the study. [ Time Frame: 1 week ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Volunteer to participate in clinical study; thoroughly informed, signed and dated the informed consent form; willing to follow and have the ability to complete all trial procedures.
- Suspicious or confirmed patients with bladder cancer.
- Age 18 or older.
- Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may visually limit cystoscopy. Where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the possible interference with cystoscopy).
- Patients who have received BCG immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure.
- Known allergy to hexaminolevulinate hydrochloride or a similar compound.
- Pregnancy or breast-feeding or women who plan to become pregnant during the trial, and men or women who are unwilling to take barrier contraceptives from 2 weeks before application of investigational medication to 28 days after application of investigational medication (Note: All women of child-bearing potential must document a negative urine pregnancy test before study inclusion and use adequate contraception during the study.
- Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
- Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- Patients that the investigator assessed unsuitable to the study.
- Subjects with contraindications to white light cystoscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05600322
|Contact: Lei Yu||+86 email@example.com|
|Cancer Hospital, Chinese Academy of Medical Sciences||Not yet recruiting|
|Beijing, Beijing, China|
|Principal Investigator: Xing Nianzeng, BMed|
|Peking University Third Hospital||Not yet recruiting|
|Beijing, Beijing, China|
|Principal Investigator: Ma Lulin, BMed|
|China, Guangzhou Province|
|Sun Yat-sen Memorial Hospital, Sun Yat-sen University||Not yet recruiting|
|Guangzhou, Guangzhou Province, China|
|Principal Investigator: Jian Huang, BMed|
|Wuhan University People's Hospital||Recruiting|
|Wuhan, Hubei, China|
|Principal Investigator: Song Chao, BMed|
|Hunan Cancer Hospital||Not yet recruiting|
|Changsha, Hunan, China|
|Principal Investigator: Han Weiqing, BMed|
|Zhongshan Hospital, Fudan University||Not yet recruiting|
|Shanghai, Shanghai, China|
|Principal Investigator: Jianming Guo|
|China, Tianjin City|
|The Second Hospital of Tianjin Medical University||Recruiting|
|Tianjin, Tianjin City, China|
|Principal Investigator: Hu Hailong, BMed|
|Principal Investigator:||Li Han Zhong, BMed||Peking Union Medical College Hospital|
|Other Study ID Numbers:||
PC B309/21 / YHCT-HEX-B1
|First Posted:||October 31, 2022 Key Record Dates|
|Last Update Posted:||February 9, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||IPD will not be shared with other researchers.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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