Pilot Study to Evaluate the Accuracy of [68Ga]Ga-PentixaFor PET/CT in the Diagnosis of Three Clinical Entities of Acute Myocardial Inflammation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion site
研究概览
简要总结
Acute myocardial inflammation is an heterogenic syndrome involving different clinical pathologies with different outcome. For the purpose of this study protocol, we focuse on three entities of this syndrome, namely the acute cellular cardiac allograft rejection (ACR), cardiac sarcoidosis (CS) and the immune checkpoint inhibitor induced myocarditis (ICIM), for which non-invasive diagnosis remains challenging.
Since accurate diagnosis of myocardial inflammation in an early stage is crucial, this study aims to investigate the accuracy of [68Ga]Ga-PentixaFor as a marker of for the presence of inflammatory cells (T-lymphocytes and M1) in described patients.
The identification of a correlation between [68Ga]Ga-PentixaFor myocardial accumulation with currently accepted diagnostic tools would open up new ways to non-invasively diagnose acute myocardial inflammation.
详细描述
Imaging will consist of administration of maximum 50 µg IV PentixaFor, labelled with 150 ±15 MBq of 68Ga, as bolus injection 60 ±15 minutes prior PET/CT
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •signed written informed consent
- •male or female
- •age ≥ 18 years
- •patients with suspicion CS (group II) or ICIM (group III) or in their regular follow-up in their first year after HT (group I)
- •SOC clinical follow-up at the cardiology department in CHUV.
排除标准
- •The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- •absence of a signed written informed consent
- •patients aged < 18 years
- •claustrophobia
- •myocardial ischemia in non-invasive perfusion test or coronarography in group II and III
- •clinically unstable cardiovascular conditions, including:
- •clinically unstable brady-tachyarrhythmia
- •severe and symptomatic hypo- or hypertension with documented systolic blood pressure < 90 mmHg or ≥220 mmHg respectively
- •cardiogenic shock.
- •women who are pregnant or breast feeding
- •intention to become pregnant during the course of the study in group II
- •previous enrolment into the current study
- •moderate to severe renal insufficiency (GFR < 45 mL/min/1,73 m2), with contra-indication to the administration of Gadolinium in group II and III
- •enrollment of the investigator, his/her family members, employees and other dependent persons
- •history of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment
- •insufficient knowledge of project language, inability to give consent or to follow procedures
- •the patient makes use of his/her "right not to know" and refuses to be informed about incidental findings
研究组 & 干预措施
cardiac sarcoidosis
[68Ga]Ga-PentixaFor PET/CT
干预措施: [68Ga]Ga-PentixaFor PET/CT (Drug)
immune checkpoint inhibitor induced myocarditis
[68Ga]Ga-PentixaFor PET/CT
干预措施: [68Ga]Ga-PentixaFor PET/CT (Drug)
acute cellular cardiac allograft rejection
[68Ga]Ga-PentixaFor PET/CT
干预措施: [68Ga]Ga-PentixaFor PET/CT (Drug)
结局指标
主要结局
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion site
时间窗: 1 year
lesion sites imaged
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - SUV
时间窗: 1 year
standard uptake value
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion number
时间窗: 1 year
lesion number imaged
次要结局
- to assess toxicity data(1 year)
研究者
John O. Prior
Head of Nuclear Medicine and Molecular Imaging Department, MD, PhD
University of Lausanne Hospitals