Randomized, Single-Blind, Monocentric, Non-Inferiority Trial of Gadopiclenol (Vueway®) Contrast Agent Performance vs. Gadobutrol (Gadovist®) in the Workup of Incidental Renal and Adrenal Findings
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Enhancement of the kidney and adrenal tissue
研究概览
简要总结
The purpose of this study is to compare the effects of the contrast agent Gadopiclenol with those of the standard contrast agent Gadobutrol.
The main question of this study is :
Does gadopiclenol offer diagnostic properties that are equally effective as those of gadobutrol?
Participants will be:
- randomly assigned to one of two groups: the experimental group, which receives gadopiclenol, or the control group, which receives gadobutrol. Each participant is informed of their group allocation prior to the magnetic resonance imaging (MRI) scan.
- invited for a single MRI appointment lasting approximately 60 minutes
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
- Single (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
- •signed informed consent
- •age ≥18 years
- •compatibility with magnetic resonance imaging
- •planned workup of kidney incidental finding or adrenal incidental findings (or both)
- •body mass index (BMI) < 31 kg/m2
排除标准
- •patients with implants that might affect imaging parameters in the region under investigation, as judged by the principal investigator
- •vulnerable individuals
- •claustrophobic individuals
- •individuals that are cognitively impaired or unable to understand the language
- •pregnant or breastfeeding patients
研究组 & 干预措施
Gadobutrol (control)
0.1 mmol/kg gadobutrol will be injected intravenously.
干预措施: Gadobutrol (Gadovist/Gadavist) (Drug)
Gadopiclenol
0.05 mmol/kg gadopiclenol will be injected intravenously.
干预措施: Gadopiclenol (Drug)
结局指标
主要结局
Enhancement of the kidney and adrenal tissue
时间窗: 60s and 15min after contrast injection during the one and only imaging session
The primary endpoint is the enhancement of the kidney and adrenal tissue (difference of T1, longitudinal relaxation time, of the organ signal before and after contrast agent application) in both contrast agent groups 60s and 15min after contrast injection.
次要结局
未报告次要终点