SAFETY AND EFFICACY EVALUATION OF DOTAREM® IN MAGNETICRESONANCE IMAGING (MRI) IN PATIENTS WITH CENTRAL NERVOUSSYSTEM (CNS) LESIONS (SENTIO Study) - SAFETY AND EFFICACY EVALUATION OF DOTAREM IN MRI OF CNS LESIONS

Conditions: Central nervous (CNS) lesions (brain and spine lesions)
MedDRA version: 12.1Level: SOCClassification code 10029205Term: NERVOUS SYSTEM DISORDERS

Registration Number: EUCTR2010-020319-34-GB

Lead Sponsor: Guerbet Laboratories Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 396

Inclusion Criteria

•Adult subject, and pediatric subjects (from aged 2 years) who will be enrolled only in Latin America and/or in the USA.
•Having been referred for a contrast-enhanced MRI of the CNS based on the results of a previous imaging procedure
•Female patients of childbearing potential 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 consented to participate after being fully informed about the study.

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) no
F.1.3.1 Number of subjects for this age range
;
•Adult subject, and pediatric subjects (from aged 2 years) who will be enrolled only in Latin America and/or in the USA.
•Having been referred for a contrast-enhanced MRI of the CNS based on the results of a previous imaging procedure
•Female patients of childbearing potential 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 consented to participate after being fully informed about the study.

Exclusion Criteria

•Having acute or chronic grade IV or V renal insufficiency
•Known class III/IV congestive heart failure
•Suffering from long QT syndrome.
•Unstable health condition or circumstances (e.g. suffering from severe claustrophobia).
•Having any contraindications to MRI such as a pace-maker, 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 having been scheduled to receive any contrast agent within 24 hours after the study contrast administration.
•Pregnant, breast feeding, or planning to become pregnant during the trial.
•Previously participated in this trial.
•Having participated within 30 days in another clinical trial involving an investigational drug.
•Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits.
•Inability or unwillingness to cooperate with the requirements of this trial.

;
•Having acute or chronic grade IV or V renal insufficiency
•Known class III/IV congestive heart failure
•Suffering from long QT syndrome.
•Unstable health condition or circumstances (e.g. suffering from severe claustrophobia).
•Having any contraindications to MRI such as a pace-maker, 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 having been scheduled to receive any contrast agent within 24 hours after the study contrast administration.
•Pregnant, breast feeding, or planning to become pregnant during the trial.
•Previously participated in this trial.
•Having participated within 30 days in another clinical trial involving an investigational drug.
•Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits.
•Inability or unwillingness to cooperate with the requirements of this trial.