A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients With Suspected Cardiac Sarcoidosis and Infective Endocarditis (FOL-CARD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Quantitative uptake of Al[¹⁸F]F-NOTA-folate measured by PET in the left ventricular myocardium in patients with suspected cardiac sarcoidosis.
研究概览
简要总结
The goal of this prospective diagnostic study is to evaluate the imaging characteristics, diagnostic performance, radiation dosimetry, and safety of Al[¹⁸F]F-NOTA-folate PET imaging in patients with suspected cardiac sarcoidosis and infective endocarditis, and healthy volunteers. The study is non-interventional with respect to clinical management, and all diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
The main aims are 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.
Participants will undergo PET imaging with Al[¹⁸F]F-NOTA-folate tracer at the Turku PET Centre. Participants with suspected cardiac sarcoidosis will undergo a second PET imaging study after initiation of immunosuppressive therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide written informed consent
- •Suspected cardiac sarcoidosis group: clinical suspicion of cardiac sarcoidosis requiring diagnostic evaluation, including cardiac magnetic resonance and/or [¹⁸F]FDG PET
- •Suspected infective endocarditis group: clinical suspicion of native or prosthetic valve infective endocarditis requiring diagnostic evaluation
- •Healthy volunteers group:
- •Age above 50 and post-menopausal (women)
- •No history of cardiovascular disease, systemic inflammatory disease, malignancy, and no active infection
排除标准
- •Pregnancy or breastfeeding
- •Known hypersensitivity to folate-based compounds or investigational medical product excipients
- •Unwillingness or inability to use effective contraception during the study participation period, in participants of childbearing potential
- •Severe renal impairment (CKD-EPI GFR <20ml/min)
- •Clinically unstable condition that, in the opinion of the investigator, would make study imaging unsafe or not feasible (e.g., haemodynamic instability, decompensated heart failure, uncontrolled clinically significant arrhythmia, suspicion of acute coronary syndrome)
- •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
- •Women of childbearing potential must have a negative pregnancy test prior to tracer administration
研究组 & 干预措施
Suspected cardiac sarcoidosis
Patients with suspected cardiac sarcoidosis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
干预措施: Al[¹⁸F]F-NOTA-folate PET imaging (Diagnostic Test)
Suspected cardiac sarcoidosis
Patients with suspected cardiac sarcoidosis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
干预措施: [15O]water PET imaging (Diagnostic Test)
Suspected cardiac sarcoidosis
Patients with suspected cardiac sarcoidosis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
干预措施: Echocardiography (Diagnostic Test)
Suspected infective endocarditis
Patients with suspected infective endocarditis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
干预措施: Al[¹⁸F]F-NOTA-folate PET imaging (Diagnostic Test)
Healthy volunteers
Healthy volunteers without known cardiovascular or systemic inflammatory disease.
干预措施: Al[¹⁸F]F-NOTA-folate PET imaging (Diagnostic Test)
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 patients with suspected cardiac sarcoidosis.
时间窗: Visit 2 (baseline imaging), no later than 7 days after initiation of systemic immunosuppressive therapy.
Quantitative uptake of Al\[¹⁸F\]F-NOTA-folate on PET in the left ventricular myocardium (global and regional standardized uptake value (SUV) measures derived from polar map analysis) in suspected cardiac sarcoidosis.
Quantitative uptake of Al[¹⁸F]F-NOTA-folate measured by PET in infected versus non-infected cardiac valves or prostheses in patients with suspected infective endocarditis
时间窗: Visit 2 (baseline imaging), performed within 14 days of enrolment and no later than 14 days after initiation of intravenous antibiotic therapy.
Quantitative uptake of Al\[¹⁸F\]F-NOTA-folate on PET in the valve/prosthesis region in suspected infective endocarditis (SUVmax and TBR = SUVmax valve/prosthesis / SUVmean blood pool).
次要结局
- Diagnostic performance of Al[¹⁸F]F-NOTA-folate PET for cardiac sarcoidosis and native or prosthetic valve infective endocarditis(From enrollment to study completion at 2 years.)
- Change in myocardial Al[¹⁸F]F-NOTA-folate uptake following immunosuppressive therapy in cardiac sarcoidosis(From Visit 2 (baseline imaging) to Visit 3 (follow-up imaging). Visit 2 is performed 7 days after initiation of systemic immunosuppressive therapy and Visit 3 is performed approximately 3 months after baseline imaging.)
- Biodistribution and radiation dosimetry of Al[¹⁸F]F-NOTA-folate(Visit 2 (imaging), performed 7-14 days after Visit 1 (screening and enrolment).)
- Incidence and severity of adverse events related to Al[¹⁸F]F-NOTA-folate(Suspected sarcoidosis and infective endocarditis groups: from Visit 2 (baseline imaging) to study completion at 2 years. Healthy volunteers: from Visit 2 to 48-72 hours, when safety laboratory tests will be obtained and AEs assessed by phone interview.)