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

• ClinicalTrials.gov Identifier: NCT05600322
• Recruitment Status: Recruiting
• First Posted: October 31, 2022
• Last Update Posted: February 9, 2023
• Sponsor: Photocure
• Collaborators: Jiangsu Yahong Meditech Co., Ltd aka Asieris; Richard Wolf GmbH; Tigermed-Jyton Co., Ltd.
• Information provided by (Responsible Party): Photocure

Tracking Information

• First Submitted Date: October 21, 2022
• First Posted Date: October 31, 2022
• Last Update Posted Date: February 9, 2023
• Actual Study Start Date: November 4, 2022
• Estimated Primary Completion Date: August 31, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 28, 2022): 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) ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 28, 2022)

• 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) ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: October 28, 2022): The proportion of patients with AEs during the study. [ Time Frame: 1 week ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• 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
• 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?

• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: N/A
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)
Primary Purpose: Diagnostic

• Condition: Bladder Cancer

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.
  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

Study Arms

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.

Interventions:

• Drug: Hexaminolevulinate Hydrochloride
• Device: Richard Wolf Photodynamic Diagnostic Equipment (PDD) system

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 28, 2022): 380
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2023
• Estimated Primary Completion Date: August 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Lei Yu; +86 13006392456; lyu@asieris.cn

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05600322
• Other Study ID Numbers: PC B309/21 / YHCT-HEX-B1
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: IPD will not be shared with other researchers.

• Current Responsible Party: Photocure
• Original Responsible Party: Same as current
• Current Study Sponsor: Photocure
• Original Study Sponsor: Same as current

Collaborators

• Jiangsu Yahong Meditech Co., Ltd aka Asieris
• Richard Wolf GmbH
• Tigermed-Jyton Co., Ltd.

Investigators

• Principal Investigator: Li Han Zhong, BMed; Peking Union Medical College Hospital

• PRS Account: Photocure
• Verification Date: February 2023