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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05600322
Recruitment Status : Not yet recruiting
First Posted : October 31, 2022
Last Update Posted : October 31, 2022
Sponsor:
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  ICMJE October 21, 2022
First Posted Date  ICMJE October 31, 2022
Last Update Posted Date October 31, 2022
Estimated Study Start Date  ICMJE October 31, 2022
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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  ICMJE Bladder Cancer
Intervention  ICMJE
  • 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 28, 2022)
380
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2023
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lei Yu +86 13006392456 lyu@asieris.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05600322
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Photocure
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Jiangsu Yahong Meditech Co., Ltd aka Asieris
  • Richard Wolf GmbH
  • Tigermed-Jyton Co., Ltd.
Investigators  ICMJE
Principal Investigator: Li Han Zhong, BMed Peking Union Medical College Hospital
PRS Account Photocure
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP