Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 416
- 试验地点
- 52
- 主要终点
- MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation
研究概览
简要总结
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.
详细描述
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®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
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 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.
研究组 & 干预措施
Dotarem (gadoterate meglumine )
Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.
干预措施: Dotarem (gadoterate meglumine) (Drug)
Magnevist (gadopentetate dimeglumine)
Dotarem and Magnevist were randomised as 2:1 ratio
干预措施: Magnevist (gadopentetate dimeglumine) (Drug)
Dotarem 2 (gadoterate meglumine )
Pediatric patients were assigned to Dotarem group only.
干预措施: Dotarem (gadoterate meglumine) (Drug)
结局指标
主要结局
MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation
时间窗: up to 24 hours
To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization. Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. "Pre" refers to unenhanced MRI. "PAIRED" refer to combined unenhanced and enhanced MRI. The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0.
次要结局
- Image Quality Score(up to 24 hours)
- Diagnostic Confidence Score(up to 24 hours)
- Number of Lesions(up to 24 hours)