2023-506971-89-00招募中3 期
A Phase III Prospective, Multicenter, Open-label Study to Assess Diagnostic Efficacy of a Novel 18F-labelled Tracer, SYN2, for Positron Emission Tomography in Subjects with Suspected Coronary Artery Disease
Synektik S.A.18 个研究点 分布在 5 个国家目标入组 170 人开始时间: 2023年11月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 18
- 主要终点
- Diagnostic performance in terms of sensitivity and specificity of qualitative expert assessment of SYN2 PET MPI against the reference standard.
研究概览
简要总结
Evaluate diagnostic performance of SYN2 PET MPI in the detection of significant CAD against the reference standard in subjects with suspected CAD.
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
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, aged over 18 years of age.
- •At the time of enrolment, the subject has been scheduled via written documentation to undergo an invasive coronary angiography for the assessment of CAD.
- •Must be capable of undergoing the pharmacological or exercise stress imaging protocols.
- •For females of reproductive potential: use of sufficiently effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one week after the last IMP administration. A sufficient contraceptive method includes mechanical barrier (e.g., a male condom or a female diaphragm), combined [estrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal anticonception associated with inhibition of ovulation [oral, injectable, implantable], IUD or IUS. Sexual abstinence is allowed when this is the preferred and usual lifestyle of the subject.
- •For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner for 3 months after last IMP exposure.
- •Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout the study duration.
排除标准
- •Subjects who have an established diagnosis of CAD as confirmed by any of the following: a. Previous myocardial infarction (MI); b. Previous coronary revascularization, such as percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
- •Female subjects who are pregnant, have a positive (+) pregnancy test, or the possibility of pregnancy cannot be ruled out prior to dosing, or the subject is breastfeeding. The females of childbearing potential must have a negative serum pregnancy test at screening and serum/urine pregnancy test within 4 hours prior to the imaging]
- •Subjects who have a mental or physical condition that prevents them from giving informed consent to participate in a clinical trial.
- •Subjects who have been committed to an institution by virtue of an order issued either by judicial or administrative authorities.
- •Known allergy or hypersensitivity for SYN2 components and other acridine derivatives such as Aminacrine, Ethacridine and Euflavine.
- •Subjects incapable of undergoing pharmacological or exercise cardiac stress testing.
- •Subjects who are unable to undergo all the imaging procedures or who have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the subject or for whom the participation may compromise the management of other diseases or the investigator judges to be unsuitable for participation in the study.
- •Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <40%).
- •Subjects with severe valvular disease (Stages C, D defined by 2020 ACC/AHA Guideline).
- •Subjects scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA (e.g., balloon angioplasty or bypass surgery).
- •Subjects undergoing evaluation for heart transplantation or with a history of heart transplantation.
- •Subjects who have taken the last dose of an Investigational Medicinal Product (IMP) from another trial within 30 days prior to enrollment in this study, and subjects scheduled to participate in another clinical study during the 7-day follow-up period of this study (except post-marketing observational clinical studies).
结局指标
主要结局
Diagnostic performance in terms of sensitivity and specificity of qualitative expert assessment of SYN2 PET MPI against the reference standard.
Diagnostic performance in terms of sensitivity and specificity of qualitative expert assessment of SYN2 PET MPI against the reference standard.
次要结局
- Diagnostic performance in terms of the area under the receiver operating characteristics (AUC-ROC) of quantitative analysis of SYN2 PET MPI against the reference standard in diagnosis of significant CAD. AUC ROC will be estimated by the trapezoidal rule.
- Adverse events and reportable serious adverse rates during the resting study as defined by the NCI Common Toxicity Criteria for Adverse Events; CTCAE v.5.0, including but not limited to changes in laboratory parameters, ECG parameters, physical examination, and vital signs.
- Diagnostic performance in terms of sensitivity and specificity of qualitative expert assessment of SYN2 PET MPI in detection of CAD against the reference standard of ICA alone and CAD defined by >70% stenosis in a major branch in subjects with suspected CAD.
- Diagnostic performance in terms of the area under the receiver operating characteristics (AUC-ROC) of quantitative perfusion analysis of SYN2 PET MPI in the detection of significant CAD by ICA alone and CAD defined by >70% stenosis in a major branch.
研究者
Przemysław Kozanecki
Scientific
Synektik S.A.
研究点 (18)
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