Efficacy and Safety of Gadopiclenol for Body 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
- 324
- 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
The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)
详细描述
The purpose of this trial was to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol in terms of lesion visualization in patients referred for contrast-enhanced MRI of body regions.
This is a prospective, international, multi-center, randomized, double-blind, controlled and cross-over trial.
This trial was conducted in 33 centers worldwide. During the course of the trial, two MRIs were obtained from each patient: one with gadopiclenol and one with gadobutrol. MRI evaluations were assessed by 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 suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol.
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 administration.
研究组 & 干预措施
gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI
Cross-over design: each patient receives gadopiclenol for the first MRI and then gadobutrol for the second MRI
干预措施: gadopiclenol (Drug)
gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI
Cross-over design: each patient receives gadopiclenol for the first MRI and then gadobutrol for the second MRI
干预措施: Gadobutrol 1 MMOLE/ML Intravenous Solution (Drug)
gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI
Cross-over design: each patient receives gadobutrol for the first MRI and then gadopiclenol for the second MRI
干预措施: gadopiclenol (Drug)
gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI
Cross-over design: each patient receives gadobutrol for the first MRI and then gadopiclenol for the second MRI
干预措施: Gadobutrol 1 MMOLE/ML Intravenous Solution (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 at patient level 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 two MRI examinations)