2025-524029-41-00招募中3 期
A Pilot Study on the Use of Gadopiclenol for Enhanced Cardiac MRI in Children with Congenital Heart Conditions: A self-controlled, non-randomised, open-label study to compare the image quality and diagnostic performance of gadopiclenol versus gadoterate meglumine
Fundacio Sant Joan De Deu1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月2日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To measure the overall image quality, including myocardium-to-blood pool contrast, and the detection of myocardial fibrosis using gadopiclenol vs. gadoterate meglumine through the diagnostic confidence, contrast-to-noise ratio (CNR), and signal-to-noise ratio (SNR).
研究概览
简要总结
To compare the image quality and diagnostic performance of gadopiclenol (0.05 mmol/kg) against gadoterate meglumine (0.1 mmol/kg) in paediatric cardiac MRI.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Fase III
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 2 and 18 years old, both included, with a clinical need for contrast-enhanced cardiac MRI.
- •Consent to participate in the study. For patients under the age of 18 (or age of consent), parent(s)/legal guardian(s) of the patient must give their consent to enrol the patient in the study. Patients >12 years and < 18 years old should sign the approved assent document.
- •A confirmed diagnosis of cardiomyopathy, tetralogy of Fallot, or complex congenital heart disease.
- •The ability to undergo MRI either without sedation or with sedation following manageable protocols.
- •Patients must have had a previous cardiac MRI using gadoterate meglumine between 12 to 24 months before recruitment.
- •People of childbearing potential (POCBP) will be included after a negative highly sensitive pregnancy test. See the Schedule of Assessments (SoA).
排除标准
- •An estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m² at screening
- •Known hypersensitivity to gadolinium-based contrast agents. Hypersensibility to any component (active ingredients or excipients) of the investigational drugs. See section 6.1 of the SmPC.
- •Non-MRI-compatible implants or devices. The usual precautions for MRI examination must be applied, such as exclusion of patients with pacemakers, ferromagnetic vascular clips, infusion pumps, nerve stimulators, cochlear implants, or suspected intracorporal metallic foreign bodies, particularly in the eye.
- •Acute cardiac failure, or hemodynamic instability.
- •Breastfeeding during the next 24h after treatment. Gadolinium-containing contrast agents are excreted into breast milk in very small amounts. At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut. Continuing or discontinuing breast feeding for a period of 24 hours after administration of Elucirem, should be at the discretion of the doctor and breast-feeding mother.
结局指标
主要结局
To measure the overall image quality, including myocardium-to-blood pool contrast, and the detection of myocardial fibrosis using gadopiclenol vs. gadoterate meglumine through the diagnostic confidence, contrast-to-noise ratio (CNR), and signal-to-noise ratio (SNR).
To measure the overall image quality, including myocardium-to-blood pool contrast, and the detection of myocardial fibrosis using gadopiclenol vs. gadoterate meglumine through the diagnostic confidence, contrast-to-noise ratio (CNR), and signal-to-noise ratio (SNR).
次要结局
- Quantitative assessment of late gadolinium enhancement (LGE) volume and mass, diagnostic confidence, SNR, CNR, and left ventricular function.
- Number of adverse events (AEs).
研究者
Emili Inarejos Clemente
Scientific
Fundacio Sant Joan De Deu
研究点 (1)
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