Clinical trial NCT05600322: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bladder Cancer
Lead sponsor: Photocure
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Yahong Meditech Co., Ltd aka Asieris
name: Richard Wolf GmbH
name: Tigermed-Jyton Co., Ltd.
First posted: 2022-10-31
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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?

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.

Primary outcomes:
measure: 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.
timeFrame: 1 day (At time of cystoscopy examination)
Secondary outcomes:
measure: Number of Subjects With at Least One Additional CIS Lesion Detected With Hexvix Blue Light Cystoscopy But Not With White Light Cystoscopy.
timeFrame: 1 day (At time of cystoscopy examination)
measure: 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).
timeFrame: 1 day (At time of cystoscopy examination)
measure: The Proportion of False Positive Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy.
timeFrame: 1 day (At time of cystoscopy examination)
Other outcomes:
measure: The Number of Patients With Adverse Events (AE) During the Study.
timeFrame: 1 week
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangzhou Province
city: Wuhan
country: China
facility: Wuhan University People's Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin City
Study officials:
affiliation: Peking Union Medical College Hospital
name: Li Han Zhong, BMed
role: PRINCIPAL_INVESTIGATOR
References: