2025-523646-27-00招募中2 期
Accuracy for Imaging Cardiac Sarcoidosis with 68Ga-Pentixafor Positron Emission Tomography/Computed Tomography (68Ga-Pentixafor PET/CT): ASPECT study
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年2月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of 68Ga-Pentixafor PET/CT in patients with (suspected) cardiac sarcoidosis. Standard of care 18F-FDG PET/CT is the reference test.
研究概览
简要总结
To evaluate the accuracy of 68Ga-Pentixafor PET/CT in imaging CS in a pilot study.
入排标准
- 年龄范围
- 18 years 至 65+ years(18-64 Years, 65+ Years)
- 接受健康志愿者
- 否
入选标准
- •Adult patients (aged 18 years or older)
- •Consensus diagnosis of extracardiac sarcoidosis
- •Patients with (suspected) cardiac sarcoidosis referred for a clinically indicated 18F-FDG PET/CT
排除标准
- •Medical history of other known cardiac infectious or inflammatory disease
- •(Possible) pregnancy in pre-menopausal women
- •Refusal to be informed about potential additional PET/CT findings.
- •Inability to provide informed consent
结局指标
主要结局
Sensitivity and specificity of 68Ga-Pentixafor PET/CT in patients with (suspected) cardiac sarcoidosis. Standard of care 18F-FDG PET/CT is the reference test.
Sensitivity and specificity of 68Ga-Pentixafor PET/CT in patients with (suspected) cardiac sarcoidosis. Standard of care 18F-FDG PET/CT is the reference test.
次要结局
- The amount of 68Ga-Pentixafor uptake in the myocardium is scored by the Qualification Visual Score for Hypermetabolism (QVSH) o 0 = None (no or less uptake than in the mediastinum) o 1 = Mild (more uptake than in the mediastinum, less than in the liver) o 2 = Moderate (more uptake than in the liver) o 3 = Severe (intense uptake)
- In case of abnormal uptake the pattern (focal, focal on diffuse or diffuse), extent, and exact location(s) of uptake is described for the left and right ventricle(19). Scoring for the uptake pattern is as follows: o 1 = No uptake o 2 = Diffuse uptake o 3 = Focal uptake o 4 = Focal on diffuse uptake If the uptake in the myocardium is focal or focal on diffuse, the location is scored according to a validated LV segmental scoring system(20).
- The standardized uptake values (SUV) is scored for quantitative assessment of tracer uptake(19).
- Myocardial suppression will be scored as: • Fully suppressed (no uptake) • Low (more than mediastinal, less than liver) • Intermediate (more than liver uptake) • High focal (much more than liver, focal) • High diffuse (much more than liver, diffuse)
- Two experienced observers will analyze the images, and findings will be compared.
- Presence of uptake in other organs suspected for sarcoidosis will be scored, including information on the affected organ.
- Time-activity curves will be used to study perfusion characteristics of the tracer.
研究者
Alexander Hirsch
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (1)
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