Patient with Central Nervous System (CNS) Lesions MedDRA version: 12.1 Level: SOC Classification code 10029205 Term: Nervous system disorders
Conditions
Interventions
Trade Name: Dotarem 0,5 mmol/ml Injektionslösung in Durchstechflaschen
Product Name: Dotarem 0.5 mmol/ml, solution for injection in vials
Product Code: G449.06
Pharmaceutical Form: Solution for inject
Sponsors
GUERBET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Adult subject (having obtained legal majority age), and pediatric subjects (aged >= 2 years) who will be enrolled only in Latin America and/or in the USA. · Having known or highly suspected of having at least one lesion with a disruption of BBB and/or with abnormal vascularity (including tumoral, vascular, inflammatory or infectious diseases) in the brain (intracranial) and spine, who are scheduled to undergo a routine contrast-enhanced MRI of the CNS. This/these lesion(s) must have been detected by previous imaging evaluation. Any of the following modalities are accepted: nuclear medicine imaging, contrast-enhanced CT, CT, contrast-enhanced MRI, MRI, or x-ray angiography. The prior imaging evaluation should be obtained within 6 months before study MRI. · If patients treated (either with radiation, surgery, biopsy, steroid, or other relevant treatments) between previous imaging evaluation and study MRI, there is still a high suspicion of remaining lesion(s) with disrupted BBB and/or with abnormal vascularity on the basis of available clinical information. · Female of childbearing potential patients must have effective contraception (contraceptive pill or intra-uterine device) or be surgically sterilized or post-menopausal (minimum 12 months amenorrhea), or have a documented negative urine pregnancy test within 24 hours prior to study MRI. · Having provided their written informed consent to participate in the study. For patients under legal majority age, the parent(s) or legal guardian of the patient must give their written informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: · Adult subject (having obtained legal majority age), and pediatric subjects (aged >= 2 years) who will be enrolled only in Latin America and/or in the USA. · Having known or highly suspected of having at least one lesion with a disruption of BBB and/or with abnormal vascularity (including tumoral, vascular, inflammatory or infectious diseases) in the brain (intracranial) and spine, who are scheduled to undergo a routine contrast-enhanced MRI of the CNS. This/these lesion(s) must have been detected by previous imaging evaluation. Any of the following modalities are accepted: nuclear medicine imaging, contrast-enhanced CT, CT, contrast-enhanced MRI, MRI, or x-ray angiography. The prior imaging evaluation should be obtained within 6 months before study MRI. · If patients treated (either with radiation, surgery, biopsy, steroid, or other relevant treatments) between previous imaging evaluation and study MRI, there is still a high suspicion of remaining lesion(s) with disrupted BBB and/or with abnormal vascularity on the basis of available clinical information. · Female of childbearing potential patients must have effective contraception (contraceptive pill or intra-uterine device) or be surgically sterilized or post-menopausal (minimum 12 months amenorrhea), or have a documented negative urine pregnancy test within 24 hours prior to study MRI. · Having provided their written informed consent to participate in the study. For patients under legal majority age, the parent(s) or legal guardian of the patient must give their written informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Having acute or chronic Grade IV or V renal insufficiency, defined as an estimated GFR<30 mL/min/1.73m² within 7 days before study MRI. · Known Class III/IV congestive heart failure according to the New York Heart Association classification; · Suffering from long QT syndrome. · Unstable health condition or circumstances (e.g. suffering from severe claustrophobia). · Having any contraindications to MRI such as a pacemaker, magnetic material or any other conditions that would preclude proximity to a strong magnetic field. · Known allergy to Gadolinium chelates. · Having received any contrast agent within 3 days prior to study contrast administration, or is scheduled to receive any contrast agent within 24 hours after the study contrast administration. · Pregnant, breastfeeding, or planning to become pregnant during the study. · Previously participated in this study. · Having participated within 30 days in another clinical study involving an investigational drug. · Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all study assessments and visits (for example: mental or physical incapacity, language comprehension, geographical localisation, etc…). · Inability or unwillingness to cooperate with the requirements of this study. ;Exclusion criteria: · Having acute or chronic Grade IV or V renal insufficiency, defined as an estimated GFR<30 mL/min/1.73m² within 7 days before study MRI. · Known Class III/IV congestive heart failure according to the New York Heart Association classification; · Suffering from long QT syndrome. · Unstable health condition or circumstances (e.g. suffering from severe claustrophobia). · Having any contraindications to MRI such as a pacemaker, magnetic material or any other conditions that would preclude proximity to a strong magnetic field. · Known allergy to Gadolinium chelates. · Having received any contrast agent within 3 days prior to study contrast administration, or is scheduled to receive any contrast agent within 24 hours after the study contrast administration. · Pregnant, breastfeeding, or planning to become pregnant during the study. · Previously participated in this study. · Having participated within 30 days in another clinical study involving an investigational drug. · Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all study assessments and visits (for example: mental or physical incapacity, language comprehension, geographical localisation, etc…). · Inability or unwillingness to cooperate with the requirements of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of Dotarem®-enhanced MRI as compared to unenhanced MRI in CNS (intracranial and spine) lesions in terms of lesion visualization (lesion border delineation, visualization of internal morphology and degree of contrast enhancement). Blinded reading performed by three independent off-site readers (neuroradiologists) will be used to assess the study primary criteria. The study will be considered successful if two of the three readers simultaneously meet co-primary objectives.;Secondary Objective: · Efficacy evaluation in terms of lesion visualization (on-site assessment). · The location and number of lesions. · Signal intensity (SI) measurement. · The quality of images. · The level of diagnostic confidence. · The safety and efficacy of Dotarem® in pediatric population. · The assessment by comparing Dotarem®-enhanced MRI to Magnevist®-enhanced MRI in terms of lesion visualization, the quality of images, the level of diagnostic confidence, the signal intensity, number and location of the lesions. · Clinical safety and biological assessment by comparing Dotarem® to Magnevist® in terms of adverse events, injection-site tolerance, changes in vital signs and ECG recordings (for a subset of the study patients) and laboratory findings (time frame: up to 24 hours post-dose). · Inter- and intra-reader agreement (off-site reading).;Primary end point(s): Lesion visualization: border delineation, visualization of internal morphology and degree of contrast enhancement assessed by off-site reading.;Main Objective: To demonstrate the superiority of Dotarem®-enhanced MRI as compared to unenhanced MRI in CNS (intracranial and spine) lesions in terms of lesion visualization (lesion border delineation, visualization of internal morphology and degree of contrast enhancement). Blinded reading performed by three independent off-site readers (neuroradiologists) will be used to assess the study primary criteria. The study will be considered succes | — |
Countries
Austria, Germany, Italy, Spain, United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed