Bladder Cancer
Conditions
Keywords
Bladder, Cancer, Cystoscopy, Hexaminolevulinate, Hexvix
Brief summary
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.
Interventions
DRUGHexaminolevulinate (Hexvix)
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.
Sponsors
GE Healthcare
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years of age. * Patients of either sex. * Patients with documented or highly suspected non-invasive bladder cancer.
Exclusion criteria
* Patients with hypersensitivity to the drug substance or any excipient of Hexvix. * Patients with porphyry. * Women of childbearing age. * Patients at a high risk of suffering extensive bladder inflammation e.g. patients after intravesical BCG treatment, patients with moderate or severe leukocyturia or patients undergoing recent bladder surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 0 (Post contrast administration) | Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 0 (Post contrast administration) | The number of confirmed bladder cancer matches using cystoscopy compared to the diagnostic gold standard, i.e. histological examination of lesions biopsy. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hexvix Use of the Hexvix drug. | 283 |
| Total | 283 |
Baseline characteristics
| Characteristic | Hexvix |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 173 Participants |
| Age, Categorical Between 18 and 65 years | 110 Participants |
| Age, Continuous | 67.5 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment Spain | 283 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 243 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 283 |
| serious Total, serious adverse events | 0 / 283 |
Outcome results
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®.
Time frame: Day 0 (Post contrast administration)
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| White-light and Blue-Light Cystoscopy Simultaneously | 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. | Tumor Stage-Carcinoma in situ | 41 Number of lesions |
| White-light and Blue-Light Cystoscopy Simultaneously | 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. | Tumor Stage-Ta | 236 Number of lesions |
| White-light and Blue-Light Cystoscopy Simultaneously | 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. | Tumor Stage- T1 | 127 Number of lesions |
| White-light and Blue-Light Cystoscopy Simultaneously | 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. | Tumor Stage- T2-T4 | 29 Number of lesions |
| White-light and Blue-Light Cystoscopy Simultaneously | 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. | Tumor could not be stage-Tx | 36 Number of lesions |
| White-light and Blue-Light Cystoscopy Simultaneously | 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. | TOTAL | 469 Number of lesions |
| White-light Cystoscopy Only | 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. | TOTAL | 6 Number of lesions |
| White-light Cystoscopy Only | 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. | Tumor Stage- T2-T4 | 3 Number of lesions |
| White-light Cystoscopy Only | 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. | Tumor Stage-Carcinoma in situ | 1 Number of lesions |
| White-light Cystoscopy Only | 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. | Tumor Stage- T1 | 0 Number of lesions |
| White-light Cystoscopy Only | 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. | Tumor Stage-Ta | 2 Number of lesions |
| White-light Cystoscopy Only | 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. | Tumor could not be stage-Tx | 0 Number of lesions |
| Blue-light Cystoscopy Only | 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. | Tumor Stage-Ta | 64 Number of lesions |
| Blue-light Cystoscopy Only | 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. | Tumor Stage- T1 | 9 Number of lesions |
| Blue-light Cystoscopy Only | 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. | Tumor Stage- T2-T4 | 2 Number of lesions |
| Blue-light Cystoscopy Only | 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. | TOTAL | 110 Number of lesions |
| Blue-light Cystoscopy Only | 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. | Tumor could not be stage-Tx | 4 Number of lesions |
| Blue-light Cystoscopy Only | 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. | Tumor Stage-Carcinoma in situ | 31 Number of lesions |
| Multiple Normalized Biopsy | 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. | Tumor could not be stage-Tx | 2 Number of lesions |
| Multiple Normalized Biopsy | 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. | TOTAL | 36 Number of lesions |
| Multiple Normalized Biopsy | 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. | Tumor Stage-Ta | 1 Number of lesions |
| Multiple Normalized Biopsy | 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. | Tumor Stage- T2-T4 | 1 Number of lesions |
| Multiple Normalized Biopsy | 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. | Tumor Stage-Carcinoma in situ | 30 Number of lesions |
| Multiple Normalized Biopsy | 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. | Tumor Stage- T1 | 2 Number of lesions |
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.
Time frame: Day 0 (Post contrast administration)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| White-light and Blue-Light Cystoscopy Simultaneously | 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. | White-Light Cystoscopy-Sensitivity | 86.3 Percentage of confirmed Lesions |
| White-light and Blue-Light Cystoscopy Simultaneously | 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. | Blue-Light Cystoscopy-Sensitivity | 90.9 Percentage of confirmed Lesions |