E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The patients should be indicated for a transurethral resection of the bladder (TURB) based on an outpatient cystoscopy and fulfil the following inclusion criteria:
• Patients with multiple bladder tumors, defined as ≥2 lesions, based on an outpatient cystoscopy.
|
|
E.1.1.1 | Medical condition in easily understood language |
Bladder cancer with more than 2 cancer lesions observed by an examination by cystoscope. |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005004 |
E.1.2 | Term | Bladder cancer NOS |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• To compare Hexvix® flexible cystoscopy and white light flexible cystoscopy in the detection of histological confirmed bladder tumor lesions defined as dysplasia; CIS; Ta; T1; and ≥ T2 after 30 minutes intravesical instillation of Hexvix®.
|
|
E.2.2 | Secondary objectives of the trial |
• To compare the detection rates of histologically confirmed bladder tumor lesions, defined as dysplasia; CIS; Ta; T1; and ≥ T2 of Hexvix® flexible cystoscopy and white light flexible cystoscopy after 30 minutes intravesical instillation of Hexvix®
• To compare the proportion of false positive lesions of Hexvix® flexible cystoscopy and white light flexible cystoscopy after 30 minutes intravesical instillation of Hexvix®
• To assess the overall fluorescence per patient for lesions seen under blue light after 30 minutes intravesical instillation of Hexvix®
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The patients should be indicated for a transurethral resection of the bladder (TURB) based on an outpatient cystoscopy and fulfil the following inclusion criteria:
• Patients with multiple bladder tumors, defined as ≥2 lesions, based on an outpatient cystoscopy.
• Patients with known urinary urge symptoms or patients who have problems or pain holding back the urine for a time longer than 30 minutes.
• Age 18 years or above
|
|
E.4 | Principal exclusion criteria |
• • Patients with known tumors in the prostatic urethra or distal urethra
• Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy).
• Patient with porphyria.
• Hypersensitivity to the active substance or to any of the excipients of the solvent
• Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
• Women of child-bearing potential
• Patients who have received BCG or chemotherapy within three months prior to study inclusion.
• Conditions associated with a risk of poor protocol compliance.
• 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
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the clinical study.
• Patients unlikely to comply with protocol
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
• The proportion of patients who have additional histology confirmed lesions defined as one of the following dysplasia; CIS; Ta; T1; and ≥ T2 demonstrated with Hexvix flexible cystoscopy but not with white light flexible cystoscopy after 30 minutes intravesical instillation of Hexvix |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Immediate mapping in both white and blue lighth, comparison of data after local pathologist evaluation of biopsies, within 3 months. |
|
E.5.2 | Secondary end point(s) |
• The detection rates of Hexvix flexible cystoscopy and white light flexible cystoscopy for all biopsies for each of the following histological results: dysplasia; CIS; Ta; T1; and ≥ T2 after 30 minutes intravesical instillation of Hexvix
• The proportion of false positive lesions of Hexvix cystoscopy and white light cystoscopy after 30 minutes intravesical instillation of Hexvix
• The proportion of patients with different fluorescence assessment scores for lesions seen under blue light flexible cystoscopy after 30 minutes intravesical instillation of Hexvix
Safety endpoint:
• The proportion of patients with drug related adverse events
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Immediate mapping in both white and blue lighth, comparison of data after local pathologist evaluation of biopsies, , within 3 months. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Retention time required for efficacy |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
within-patient controlled |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
compared to white light cystoscopy only |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |