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. MedDRA version: 14.0 Level: LLT Classification code 10005004 Term: Bladder cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Hexvix
Pharmaceutical Form: Powder for solution for intravesical use
INN or Proposed INN: HEXAMINOLEVULINATE
CAS Number: 140898-91-5
Other descriptive name: HEXAMINOLEVULINATE HYDROCHLORI
Sponsors
Photocure ASA
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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®. ;Secondary Objective: • 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® ;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;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;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. | — |
Countries
Germany
Contacts
Public ContactAndreas Grund
GCP Service International Ltd. & CoKG
Outcome results
None listed