Safety and Efficacy Evaluation of DOTAREM® in Magnetic Re... | EligiMed

Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.

CompletadoFase 3ClinicalTrials.gov

ID: NCT01211873Tipo: INTERVENTIONALInicio: 1 de sept de 2010Fin estimado: 1 de nov de 2011

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.

Descripción detallada

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Dotarem®. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Dotarem® when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Dotarem®.

Elegibilidad

Edad mínima: 2 YearsSexo: ALL

Criterios de inclusión

Adult subject and pediatric subjects (aged greater than or equal to two (2) years).
Is referred for a contrast-enhanced MRI of the CNS based on the results of a previous imaging procedure.
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.
Has been fully informed about the study, and has consented to participate.

Criterios de exclusión

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 is 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.

Intervenciones

drug

Dotarem (gadoterate meglumine)

0.1 mmol/kg by body weight, single IV injection

drug

Magnevist (gadopentetate dimeglumine)

0.1 mmol/kg by body weight, single IV injection

Ubicaciones

Centro de Diagnóstico

Buenos Aires, Argentina

Hospital Italiano

Buenos Aires, Argentina

TCBA

Buenos Aires, Argentina

Patrocinadores

PrincipalGuerbet

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