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

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05600322
• Other study ID #: PC B309/21 / YHCT-HEX-B1
• Status: Completed
• Phase: Phase 3
• Start date: November 3, 2022
• Est. completion date: July 12, 2023

Study information

• Verified date: November 2023
• Source: Photocure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Suspicious or confirmed patients with bladder cancer.

3. Age 18 or older.

Exclusion Criteria:

1. 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).

2. Patients who have received BCG immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure.

3. Porphyria.

4. Known allergy to hexaminolevulinate hydrochloride or a similar compound.

5. 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.

6. Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.

7. 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.

8. Patients that the investigator assessed unsuitable to the study.

9. Subjects with contraindications to white light cystoscopy.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangzhou Province
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	The Second Hospital of Tianjin Medical University	Tianjin	Tianjin City
China	Wuhan University People's Hospital	Wuhan	Hubei

Sponsors (4)

Lead Sponsor	Collaborator
Photocure	Jiangsu Yahong Meditech Co., Ltd aka Asieris, Richard Wolf GmbH, Tigermed-Jyton Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The proportion of patients with AEs during the study.		1 week
Primary	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.		1 day (At time of cystoscopy examination)
Secondary	Proportion of subjects with at least one additional CIS lesion detected with Hexvix blue light cystoscopy but not with white light cystoscopy.		1 day (At time of cystoscopy examination)
Secondary	The lesion detection rate of Hexvix blue light cystoscopy and white light cystoscopy for following lesion types (PUNLMP, CIS, Ta, T1, T2-T4).		1 day (At time of cystoscopy examination)
Secondary	The proportion of false positive lesions detected with Hexvix blue light cystoscopy and white light cystoscopy.		1 day (At time of cystoscopy examination)