Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 260
- 试验地点
- 33
- 主要终点
- Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
研究概览
简要总结
This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
详细描述
The purpose of this trial was to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol injection for Central Nervous System (CNS) lesion detection and visualization by conventional steady-state CNS imaging.
This is a multi-center, international, prospective, double-blind, randomized, controlled, cross-over with comparator trial in male and female patients presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) who are scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of the CNS.
This trial was conducted in 33 centers worldwide.
During the course of the trial, two MRIs were obtained from each patient: one unenhanced and gadopiclenol-enhanced MRI; and one unenhanced and gadobutrol-enhanced MRI. MRI evaluations were performed by on-site investigators and three independent off-site blinded readers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to ICF signature.
排除标准
- •Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent injection
- •Patient presenting extra cranial lesions and/or extra-dural lesions.
研究组 & 干预措施
gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI
cross-over design. each patient will receive gadopiclenol for the first MRI and gadobutrol for the second MRI
干预措施: gadopiclenol (Drug)
gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI
cross-over design. each patient will receive gadopiclenol for the first MRI and gadobutrol for the second MRI
干预措施: Gadobutrol 1Mmol/mL Solution for Injection Vial (Drug)
gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI
cross-over design. each patient will receive gadobutrol for the first MRI and gadopiclenol for the second MRI
干预措施: gadopiclenol (Drug)
gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI
cross-over design. each patient will receive gadobutrol for the first MRI and gadopiclenol for the second MRI
干预措施: Gadobutrol 1Mmol/mL Solution for Injection Vial (Drug)
结局指标
主要结局
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
时间窗: At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI.
The lesion visualization (per patient) was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor \[internal morphology\] or none \[border delineation, contrast enhancement\], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each co-criterion was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between Paired \[unenhanced and contrast-enhanced\] images and Pre-contrast \[unenhanced\] images was calculated for each of the 3 co-primary criteria and for each reader.
次要结局
- Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI(At each of two MRI examinations with an interval of 2-14 days between 2 MRI examinations)