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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-03

Study Completion Date

2023-07-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer

NCT00052637

Bladder Cancer

COMPLETED PHASE3

Detection of Bladder Tumors After 30 Min Instillation of Hexvix

NCT01551407

Bladder Cancer

TERMINATED PHASE2

Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy

NCT00233402

Bladder Cancer

COMPLETED PHASE3

Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB

NCT01166230

Bladder Cancer

COMPLETED

A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer

NCT00412971

Bladder Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Hexaminolevulinate Hydrochloride

Intervention Type 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.

Richard Wolf Photodynamic Diagnostic Equipment (PDD) system

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Richard Wolf Photodynamic Diagnostic Equipment (PDD) system

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hexvix System Blue

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No