LowEr Administered Dose With highEr Relaxivity: Gadovist vs Dotarem (LEADER 75)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 157
- 试验地点
- 20
- 主要终点
- Lesion Border Delineation
研究概览
简要总结
The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is applied to improve the analysability of MRI-images.
The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.
详细描述
The study was an open-label, multi-center, comparative, cross-over trial in adult patients with known or highly suspected CNS pathology who were referred for imaging of the CNS.
The primary objective of the study was to demonstrate the non-inferiority of gadobutrol (0.075 mmol/ kg body weight) to gadoterate (0.1 mmol/ kg body weight).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known or highly suspected central nervous system (CNS) pathology referred for contrast-enhanced MRI of the CNS.
- •Glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m2 derived from a serum creatinine result within four weeks prior to the first study MRI.
- •Women with negative urine pregnancy test within 1 hour prior to the administration of gadoterate (the first MRI).
排除标准
- •No enhancing lesion visible on the gadoterate-enhanced MRI scan.
- •Pregnancy or breastfeeding.
- •Severe cardiovascular disease
研究组 & 干预措施
Arm 1_Suspected CNS-lesion
Patients with suspected or confirmed CNS-lesions underwent unenhanced MRI, and contrast-enhanced MRI after gadoterate injection.
干预措施: Gadoterate (Dotarem/Clariscan) (Drug)
Arm 2_Confirmed CNS-lesion
Patients with gadoterate-confirmed CNS-lesions (subgroup of Arm 1) underwent a second unenhanced MRI, and contrast-enhanced MRI after gadobutrol injection.
干预措施: Gadoterate (Dotarem/Clariscan) (Drug)
Arm 2_Confirmed CNS-lesion
Patients with gadoterate-confirmed CNS-lesions (subgroup of Arm 1) underwent a second unenhanced MRI, and contrast-enhanced MRI after gadobutrol injection.
干预措施: Gadobutrol (Gadavist/Gadovist, BAY86-4875) (Drug)
结局指标
主要结局
Lesion Border Delineation
时间窗: Up to 20 days
Lesion border delineation is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded readers scored the delineation of up to 5 lesions using image sequences and a 4-point scale (1 - None = No or unclear delineation; 2 - Moderate = Partial delineation; 3 - Good = Almost clear, but incomplete delineation; 4 - Excellent = Clear and complete delineation).
Degree of Lesion Contrast Enhancement
时间窗: Up to 20 days
Degree of lesion contrast enhancement is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored up to 5 lesions using image sequences and a 4-point scale (1 - No = Lesion not enhanced; 2 - Moderate = Lesion weakly enhanced; 3 - Good = Lesion clearly enhanced; 4 - Excellent = Lesion clearly and brightly enhanced).
Lesion Internal Morphology
时间窗: Up to 20 days
Lesion internal morphology is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored the structure and internal morphology of up to 5 lesions using image sequences and a 3-point scale (1 - Poor = Poor visibility; 2 - Moderate = Partial visibility; 3 - Good = Sufficient visibility)
次要结局
- Image Quality(Up to 20 days)
- Contrast Enhancement Utilizing an Exploratory Overall Contrast Enhancement Estimation Algorithm(Up to 20 days)
- Number of Participants With Treatment-emergent Adverse Events(From the first study drug administration up to 24 hours post injection)
- Number of Lesions Identified(Up to 20 days)
- Detection of Malignant Disease(Up to 20 days)
- Confidence in Diagnosis(Up to 20 days)