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| Name | Class |
|---|---|
| Jiangsu Yahong Meditech Co., Ltd aka Asieris | INDUSTRY |
| Richard Wolf GmbH | INDUSTRY |
| Tigermed-Jyton Co., Ltd. | INDUSTRY |
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A study to compare Hexvix Blue light cstoscopy with standard White light cystoscopy in the detection of bladder cancer.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With Adverse Events (AE) During the Study. | 1 week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Han Zhong, BMed | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China | |||
| Peking University Third Hospital |
IPD will not be shared with other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2023 |
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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.
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|
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| Richard Wolf Photodynamic Diagnostic Equipment (PDD) system | Device | Cystoscopy in White and Blue light will be done using the Richard Wolf PDD system. |
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| 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) |
| Beijing |
| Beijing Municipality |
| China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangzhou Province | China |
| Wuhan University People's Hospital | Wuhan | Hubei | China |
| Hunan Cancer Hospital | Changsha | Hunan | China |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | China |
| The Second Hospital of Tianjin Medical University | Tianjin | Tianjin City | China |
| COMPLETED |
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| NOT COMPLETED |
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In the group of 158 enrolled subjects, 37 subjects were training patients. To reduce possible bias in the assessment of the objectives, 6 subjects were randomized to not continue with blue light cystoscopy. In addition, 1 patient withdrew. Baseline characteristics are reported for the 114 subjects that underwent both white and blue light cystoscopy.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients with histology-confirmed lesions (Ta, T1, or CIS) were included in the Modified Full Analysis Set (mFAS) | Posted | Count of Participants | Participants | 1 day (At time of cystoscopy examination) |
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| Secondary | Number of Subjects With at Least One Additional CIS Lesion Detected With Hexvix Blue Light Cystoscopy But Not With White Light Cystoscopy. | Patients randomised to undergo white light cystoscopy and Hexvix blue light cystoscopy were included in the Full Analysis Set (FAS) | Posted | Count of Participants | Participants | 1 day (At time of cystoscopy examination) |
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| ||||||||||||||||||||||||||||
| 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). | The total number of lesions in the full analysis set | Posted | Number | 95% Confidence Interval | percentage of lesions | 1 day (At time of cystoscopy examination) | Lesions | Lesions |
|
| |||||||||||||||||||||||||
| Secondary | The Proportion of False Positive Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy. | Patients that were randomised to undergo standard White light cystoscopy and Hexvix Blue light cystoscopy. | Posted | Number | 95% Confidence Interval | percentage of false positive lesions | 1 day (At time of cystoscopy examination) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | The Number of Patients With Adverse Events (AE) During the Study. | Patients who received Hexvix instillation were included in the safety population. | Posted | Count of Participants | Participants | 1 week |
|
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Approx. 3 weeks, including time from screening visit (- 2 weeks) until safety follow-up of 1 week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 158 | 0 | 158 | 95 | 158 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.0 (ENG) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 (ENG) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Bladder spasm | Renal and urinary disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Bladder pain | Renal and urinary disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Ureteral spasm | Renal and urinary disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Urethral syndrome | Renal and urinary disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Urinary tract pain | Renal and urinary disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
| |
| Urinary tract spasm | Renal and urinary disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Blood albumin decreased | Investigations | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Fibrin D dimer increased | Investigations | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Dyschezia | Gastrointestinal disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Inflammation | General disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Peripheral venous disease | Vascular disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Venous thrombosis limb | Vascular disorders | MedDRA 25.0 (ENG) | Systematic Assessment |
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| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Laryngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.0 (ENG) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Director | Photocure ASA | +4722062210 | research@photocure.com |
| Dec 20, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C419924 | 5-aminolevulinic acid hexyl ester |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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