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The purpose of this study is to determine the effectiveness of hexaminolevulinate (Hexvix) in the diagnosis and treatment of patients with non-invasive bladder cancer and if it results in a change in patient management.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hexaminolevulinate (Hexvix) | Drug | Each patient enrolled into the study will be infused with 50 mL of a 2 mg/mL Hexvix solution in the bladder using a catheter. Subsequently, after fluid retention by the patient in the bladder for one hour, the bladder will be emptied. |
| Measure | Description | Time Frame |
|---|---|---|
| Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy. | Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®. | Day 0 (Post contrast administration) |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Sensitivity of Standard White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC) for Obtaining a Correct Diagnosis of Bladder Cancer at Individual Patient Level. | The number of confirmed bladder cancer matches using cystoscopy compared to the diagnostic gold standard, i.e. histological examination of lesions biopsy. | Day 0 (Post contrast administration) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with documented or suspected bladder cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Carlos Hernández | Gregorio Marañón Hospital, Madrid | Principal Investigator |
| Dr. Eduardo Solsona | Valencian Institute of Oncology, Valencia | Principal Investigator |
| Dr. Joan Palou | Fundación Puigvert, Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Madrid | 28108 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hexvix 2 mg/mL Infusion | Administrtation of 2 mg/mL Hexvix. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hexvix | Use of the Hexvix drug. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy. | Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®. | Number of True-positive lesions according to histology was 621 and broken out into various tumor stages. The Tumor stage distribution of true-positive bladder tumor lesions and their detection by White-light Cystoscopy (WLC) and/or Blue-light Cystoscopy (BLC). | Posted | Number | Number of lesions | Day 0 (Post contrast administration) |
|
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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 | Use of the Hexvix drug. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emilio Moreno Carretero, M.D. | GE Healthcare | 011-34-9166-30970 | Emilio.Morenocarretero@ge.com |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C419924 | 5-aminolevulinic acid hexyl ester |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | White-light Cystoscopy Only | Hexvix administered using only White-light Cystoscopy. |
| OG002 | Blue-light Cystoscopy Only | Hexvix administered using only Blue-light Cystoscopy. |
| OG003 | Multiple Normalized Biopsy | Only Multiple Normalized Biopsy. |
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| Secondary | Assess the Sensitivity of Standard White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC) for Obtaining a Correct Diagnosis of Bladder Cancer at Individual Patient Level. | The number of confirmed bladder cancer matches using cystoscopy compared to the diagnostic gold standard, i.e. histological examination of lesions biopsy. | The number of confirmed bladder cancer was 219 identified by the standard of truth methods using the White-light cystoscopy and blue-light cystoscopy technique. | Posted | Number | 95% Confidence Interval | Percentage of confirmed Lesions | Day 0 (Post contrast administration) |
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| 0 |
| 283 |
| 0 |
| 283 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |