2026-526655-59-00招募中2 期
A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients with Suspected Cardiac Sarcoidosis or Infective Endocarditis and Healthy Volunteers (FOL-CARD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 143
- 试验地点
- 3
- 主要终点
- Quantitative uptake of Al[18F]F-NOTA-folate measured by PET in the left ventricular myocardium in suspected cardiac sarcoidosis and in valvular regions in suspected infective endocarditis
研究概览
简要总结
To evaluate quantitative uptake of Al[18F]F-NOTA-folate measured by PET imaging in the left ventricular myocardium of patients with suspected cardiac sarcoidosis, and in cardiac valves or prosthetic valve regions in patients with suspected infective endocarditis
研究设计
- 分配方式
- Na
- 主要目的
- Clinical and safety follow-up (Visit 4)
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient with a clinical suspicion of cardiac sarcoidosis requiring diagnostic evaluation with clinically indicated cardiac magnetic resonance and/or [18F]FDG PET, and at least 18 years of age
- •Clinical suspicion of native or prosthetic valve infective endocarditis requiring diagnostic evaluation and at least 18 years of age
- •Healthy volunteer ageing at least 50 years, post-menopausal (women) and no history of cardiovascular disease, systemic inflammatory disease, cancer, and no active infection
- •Ability to provide written informed consent
排除标准
- •Pregnancy or breastfeeding
- •Known hypersensitivity to folate-based compounds or investigational medical product excipients
- •For women of childbearing potential: unwillingness or inability to use a highly effective method of contraception from study inclusion throughout the period during which Al[¹⁸F]F-NOTA-folate administration may occur and for 24 hours after the last administration (Women of childbearing potential must have a negative highly sensitive urine or serum pregnancy test within 24 hours prior to each administration of Al[¹⁸F]F-NOTA-folate)..
- •Clinically unstable condition that, in the opinion of the investigator, would make study imaging unsafe or not feasible
- •Systemic immunosuppressive therapy for more than 7 days prior to baseline Al[18F]F-NOTA-folate PET imaging
- •Inability to complete protocol-defined study procedures
- •Severe renal dysfunction (CKD-EPI GFP <20 ml/min/1,73 m2)
- •Intravenous antibiotic therapy for more than 14 days
研究组 & 干预措施
Al[ 18 F]F-NOTA-folate
Test
干预措施: Al[ 18 F]F-NOTA-folate (Drug)
结局指标
主要结局
Quantitative uptake of Al[18F]F-NOTA-folate measured by PET in the left ventricular myocardium in suspected cardiac sarcoidosis and in valvular regions in suspected infective endocarditis
Quantitative uptake of Al[18F]F-NOTA-folate measured by PET in the left ventricular myocardium in suspected cardiac sarcoidosis and in valvular regions in suspected infective endocarditis
次要结局
- Diagnostic performance of Al[18F]F-NOTA-folate PET for cardiac sarcoidosis and native or prosthetic valve infective endocarditis
- Change in myocardial Al[18F]F-NOTA-folate uptake following immunosuppressive therapy in cardiac sarcoidosis
- Biodistribution, stability, and radiation dosimetry of Al[18F]F-NOTA-folate in healthy volunteers
- Incidence and severity of adverse events related to Al[18F]F-NOTA-folate
研究者
Antti Saraste
Scientific
Turku University Hospital
研究点 (3)
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