EUCTR2010-020319-34-GB进行中（未招募）不适用
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
Guerbet Laboratories Ltd.0 个研究点目标入组 396 人开始时间: 2010年10月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 396
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •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
排除标准
- •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.
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