Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (e.g., primary and secondary tumors) MedDRA version: 20.1 Level: LLT Classification code 10056941 Term: MRI brain System Organ Class: 100000004848 MedDRA version: 20.1 Level: LLT Classification code 10056922 Term: MRI brain abnormal System Organ Class: 100000004848
Conditions
Interventions
Product Name: gadopiclenol
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GADOPICLENOL
CAS Number: 933983-75-6
Current Sponsor code: P03277, G03277
Concentration unit: mol/l mole(s)/
Sponsors
Guerbet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female or male adult patient (patient having reached legal majority age). - Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to ICF signature. - Patient scheduled for a CNS contrast-enhanced MRI examination for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the trial. - Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent prior to any trial related procedure being conducted. Some other inclusion criteria are listed in the trial protocol 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Patient presenting extra cranial lesions and/or extra-dural lesions. - Patient presenting with an acute relapse of multiple sclerosis as qualifying CNS lesion. - Patient presenting with any contraindication to MRI examinations. - Patient previously randomized in this trial. - Patient having received any contrast agent (MRI or CT) within 3 days prior to first trial product administration, or scheduled to receive any contrast agent during the course of the trial or within 24 hours after the second trial product administration. Some other exclusion criteria are listed in the trial protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To demonstrate the superiority of gadopiclenol-enhanced MRI at 0.05 mmol/kg body weight (BW) compared to unenhanced MRI for patient referred for contrast-enhanced MRI of CNS, in terms of 3 lesion visualization co-primary criteria using the patient as his/her own control. - To demonstrate the non-inferiority of gadopiclenol at 0.05 mmol/kg compared to gadobutrol at 0.1 mmol/kg in terms of 3 lesion visualization co-primary criteria for patient referred for contrast-enhanced MRI of CNS.;Secondary Objective: - To assess visualization parameters with gadopiclenol and gadobutrol - To assess the safety profile of gadopiclenol and gadobutrol;Primary end point(s): Lesion visualization criteria based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol (criteria 1) and the MRI performed with gadopiclenol and those performed with gadobutrol (criteria 2);Timepoint(s) of evaluation of this end point: After the 2nd contrast injection / MRI | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Visualization parameters with gadopiclenol and gadobutrol (e.g. lesion visualization assessment by investigator, number, size and location of lesions ...) Safety profile of gadopiclenol and gadobutrol;Timepoint(s) of evaluation of this end point: After the 2nd contrast injection / MRI At the end of the patient's participation | — |
Countries
Belgium, Bulgaria, France, Germany, Hungary, Italy, Korea, Republic of, Mexico, Poland, Spain, Taiwan, United States
Contacts
Public ContactLucie Begert
Guerbet
Outcome results
None listed