High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Non-inferiority of half dose of Elucirem to double dose Dotarem
研究概览
简要总结
Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. The product was approved in 2022 by FDA to be used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). However, given its at least twofold higher relaxivity than other GBCAs, the performance of Elucirem in cardiac MR (CMR) has yet to be demonstrated.
The hypothesis for the study: Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment.
All participants will be selected from the investigators previous CMR study cohort with double-dose Dotarem T1 mapping and LGE images. Ten participants without scars will be recruited for the Phase I dose evaluation. Five for 0.05 mmol/kg and five for 0.075 mmol/kg. The investigators have identified 15 participants with LGE findings from double-dose Dotarem CMR acquired in the years 2021, 2022, or earlier years. This study was performed in August 2022. The same protocol will be used for single-dose Elucirem.
详细描述
Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. The product was approved in 2022 by FDA to be used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
Based on the investigators previous experience with 0.2 mmol/kg Dotarem, the optimal post-contrast T1 for LGE was when the remote myocardium (i.e. area without scar) had T1 of around 400ms at 12 mins post-contrast. The investigators hypothesize that with 0.05 mmol/kg Elucirem, post T1 will recover to 400 ms faster than 12 minutes after injection. It will likely be between 6 to 10 minutes post-contrast. A serial of T1 mapping will provide the information for timing. However, if myocardial T1 were not reduced short enough or recovers to 400 ms in less than 5 minutes post-contrast with 0.05 mmol/kg Elucirem, that is a sign of inadequate dose. Same evaluation will be performed for 0.075 mmol/kg Elucirem. The investigators hypothesize that if 0.05 mmol/kg falls short, 0.075 mmol/kg should be adequate. Since a single dose (0.1 mmol/kg) of Dotarem is proved to be adequate for LGE in many literatures, less Elucirem should be used to demonstrate its benefit.
Study Procedure: It is a non-randomized cohort study. Participants with precious double dose Dotarem CMR will be recruited. The study has two phases. Phase I is to evaluate the optimal dose, 0.05 mmol/kg (N=5) or 0.075 mmol/kg (N=5) by assessing a serial of the myocardial T1 mapping in normal volunteers. T1 mapping will be acquired every 2.5 minutes after injection to 25 minutes post-contrast. Based on the results of Phase I, the optimal dose will be used in the Phase II scar assessment in patients with a scar from a previous double-dose Dotarem study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants from previous double-dose Doatrem CMR study who are willing to participate and sign the consent will be enrolled in this study. Participants must be ≥21 years old, less than 120kg, not claustrophobic, and eGFR be 60 and more.
排除标准
- •Participants under 21 years old will be excluded. Contraindications or limitations to contrast-enhanced MRI such as self-report of kidney disease, including kidney transplant or kidney surgery, eGFR less than 60, Metal fragments in eyes, brain, or spinal cord, Internal electrical devices such as cochlear implant, spinal cord stimulator, pacemaker, or defibrillator, pregnancy, allergic reaction to gadolinium in the past, claustrophobia, and cardiogenic shock or unstable condition that cannot tolerate the MRI scan will be excluded.
研究组 & 干预措施
0.05 mmol/kg Elucirem
a group that receives 0.05 mmol/kg Elucirem
干预措施: Elucirem (Gadopiclenol) (Drug)
0.075 mmol/kg Elucirem
A group that receives 0.075 mmol/kg Elucirem
干预措施: Elucirem (Gadopiclenol) (Drug)
结局指标
主要结局
Non-inferiority of half dose of Elucirem to double dose Dotarem
时间窗: 1-2 years
Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment.
次要结局
- Post-contrast T1 values(1-2 years)
- Extracellular volume fraction (ECV)(1-2 years)
- late gadolinium enhancement (LGE),(1-2 years)