ELUDYN: Assessment of Intra-individual Variability of Vascular Dynamics of Gadopiclenol Injection Parameters in Contrast-enhanced MRI
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Qualitative evaluation of MRI images
研究概览
简要总结
This study aims to understand how the volumes and speeds of intravenous injection of a recent type of contrast agent can be optimized in order to improve the information provided by medical images. To do this, five MRI scans lasting approximately 30 minutes will be performed on 10 healthy volunteers over a period of approximately 10 months. The images will then be analyzed by three radiologists who will view the images in different orders, without knowing which injection parameters were used. They will decide, based on their impressions but also on precise measurements in the images, which parameters produce the best images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥18 and ≤ 40 years of age at time of Informed Consent
- •Informed Consent as documented by signature
- •No known chronic conditions (defined by ICD-10 codes)
- •Non-smoking
- •French speaking
排除标准
- •Women who are pregnant or breast feeding,
- •Intention to become pregnant during the course of the study,
- •Contraindications to the class of drug (gadopiclenol and gadoteric acid) under study, e.g. known hypersensitivity or allergy
- •Claustrophobia and contraindication for MRI according to institutional practices
- •Prior MRI examination with contrast agent and washout period of ≤ 2 weeks
- •Prior liver, spleen, pancreatic or bowel surgery
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Participation in another study with investigational medicinal product within the 30 days preceding and during the present study
研究组 & 干预措施
Injection protocol 5: gadoteric acid 1 mL/s
干预措施: contrast agent, Gadolinium (Drug)
Injection protocol 1: gadopiclenol 2 mL/s
干预措施: contrast agent, Gadolinium (Drug)
Injection protocol 3: gadopiclenol 0.5 mL/s
干预措施: contrast agent, Gadolinium (Drug)
Injection protocol 4: gadopiclenol half dose
干预措施: contrast agent, Gadolinium (Drug)
Injection protocol 2: gadopiclenol 1 mL/s
干预措施: contrast agent, Gadolinium (Drug)
结局指标
主要结局
Qualitative evaluation of MRI images
时间窗: October 2026
The qualitative evaluation of the MRI images, as assessed by the median composite score of three five-items Likert scales (0 = non-diagnostic or unacceptable; 1 = poor; 2 = fair; 3 = good; 4 = excellent) across the rating of three experienced radiologists. The three Likert scales concern i) the border delineation of the vessel measured using slopes perpendicular to the vessel walls, ii) the internal homogeneity in the vessel, and iii) the visual degree of contrast enhancement. The composite score thus ranges from 0 to 12 for each reader and then the middle score (i.e., the median) between all three readers is taken for increased reliability.
Qualitative evaluation of MRI images
时间窗: June 2027
The qualitative evaluation of the MRI images, as assessed by the median composite score of three five-items Likert scales (0 = non-diagnostic or unacceptable; 1 = poor; 2 = fair; 3 = good; 4 = excellent) across the rating of three experienced radiologists. The three Likert scales concern i) the border delineation of the vessel measured using slopes perpendicular to the vessel walls, ii) the internal homogeneity in the vessel, and iii) the visual degree of contrast enhancement. The composite score thus ranges from 0 to 12 for each reader and then the middle score (i.e., the median) between all three readers is taken for increased reliability.
次要结局
未报告次要终点