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

NCT05600322 | Completed Phase 3 Results

• 1 other identifier: PC B309/21 / YHCT-HEX-B1
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 day (At time of cystoscopy examination)

Secondary Outcomes (3)

• Number 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)

• Number of Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy for Following Lesion Types (Papillary Urothelial Neoplasm of Low Malignant Potential (PUNLMP), Carcinoma in Situ (CIS), Ta, T1, T2-T4).

  1 day (At time of cystoscopy examination)

• The Proportion of False Positive Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy.

  1 day (At time of cystoscopy examination)

Other Outcomes (1)

• The Number of Patients With Adverse Events (AE) During the Study.

  1 week

Study Arms (1)

Hexvix Blue light cystoscopy

EXPERIMENTAL

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; Device: Richard Wolf Photodynamic Diagnostic Equipment (PDD) system

Interventions

Hexaminolevulinate Hydrochloride DRUG

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.

Also known as: Hexvix

Hexvix Blue light cystoscopy

Richard Wolf Photodynamic Diagnostic Equipment (PDD) system DEVICE

Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.

Also known as: System Blue

Hexvix Blue light cystoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Porphyria.
• Known allergy to hexaminolevulinate hydrochloride or a similar compound.
• 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.

Sponsors & Collaborators

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

Study Sites (7)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangzhou Province, China

Location

Wuhan University People's Hospital

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin City, China

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

5-aminolevulinic acid hexyl ester; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Clinical Director
• Organization: Photocure ASA

research@photocure.com

+4722062210

Study Officials

• Li Han Zhong, BMed

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 31, 2022
• Study Start: November 3, 2022
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: October 3, 2024
• Results First Posted: October 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)