Bladder Cancer
Conditions
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?
Interventions
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.
DEVICERichard Wolf Photodynamic Diagnostic Equipment (PDD) system
Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system.
Sponsors
Jiangsu Yahong Meditech Co., Ltd aka Asieris
Richard Wolf GmbH
Tigermed-Jyton Co., Ltd.
Photocure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1 day (At time of cystoscopy examination) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The Number of Patients With Adverse Events (AE) During the Study. | 1 week |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
Richard Wolf Photodynamic Diagnostic Equipment (PDD) system: Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system. | 114 |
| Total | 114 |
Baseline characteristics
| Characteristic | Hexvix Blue Light Cystoscopy |
|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 12.18 |
| Race/Ethnicity, Customized Han nationality | 112 Participants |
| Race/Ethnicity, Customized Others | 2 Participants |
| Region of Enrollment China | 114 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 158 |
| other Total, other adverse events | 95 / 158 |
| serious Total, serious adverse events | 0 / 158 |
Outcome results
Primary
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.
Time frame: 1 day (At time of cystoscopy examination)
Population: Patients with histology-confirmed lesions (Ta, T1, or CIS) were included in the Modified Full Analysis Set (mFAS)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hexvix Blue Light Cystoscopy | 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. | 42 Participants |
Secondary
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).
Time frame: 1 day (At time of cystoscopy examination)
Population: The total number of lesions in the full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hexvix Blue Light Cystoscopy | 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). | T2-T4 lesion detection rate Blue light | 100 percentage of lesions |
| Hexvix Blue Light Cystoscopy | 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). | PUNLMP lesion detection rate Blue light | 0 percentage of lesions |
| Hexvix Blue Light Cystoscopy | 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). | PUNLMP lesion detection rate White light | 0 percentage of lesions |
| Hexvix Blue Light Cystoscopy | 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). | CIS lesion detection rate Blue light | 94.7 percentage of lesions |
| Hexvix Blue Light Cystoscopy | 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). | CIS lesion detection rate White light | 42.1 percentage of lesions |
| Hexvix Blue Light Cystoscopy | 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). | Ta lesion detection rate Blue light | 100 percentage of lesions |
| Hexvix Blue Light Cystoscopy | 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). | Ta lesion detection rate White light | 76.1 percentage of lesions |
| Hexvix Blue Light Cystoscopy | 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). | T1 lesion detection rate Blue light | 98.2 percentage of lesions |
| Hexvix Blue Light Cystoscopy | 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). | T1 lesion detection rate White light | 91.2 percentage of lesions |
| Hexvix Blue Light Cystoscopy | 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). | T2-T4 lesion detection rate White light | 100 percentage of lesions |
Secondary
Number 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)
Population: Patients randomised to undergo white light cystoscopy and Hexvix blue light cystoscopy were included in the Full Analysis Set (FAS)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hexvix Blue Light Cystoscopy | Number of Subjects With at Least One Additional CIS Lesion Detected With Hexvix Blue Light Cystoscopy But Not With White Light Cystoscopy. | 11 Participants |
Secondary
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)
Population: Patients that were randomised to undergo standard White light cystoscopy and Hexvix Blue light cystoscopy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hexvix Blue Light Cystoscopy | The Proportion of False Positive Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy. | False positive detection rate Blue light | 23.2 percentage of false positive lesions |
| Hexvix Blue Light Cystoscopy | The Proportion of False Positive Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy. | False positive detection rate White light | 16.0 percentage of false positive lesions |
Other Pre-specified
The Number of Patients With Adverse Events (AE) During the Study.
Time frame: 1 week
Population: Patients who received Hexvix instillation were included in the safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hexvix Blue Light Cystoscopy | The Number of Patients With Adverse Events (AE) During the Study. | 95 Participants |