NCT06566209终止不适用
Positron Emission Tomography for the Detection of Subclinical Immune Checkpoint Inhibitor-Induced Myocarditis (PET-SIM): A Prospective, Single Center, Single Arm, Open Label Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Presennce of inflammation or scarring
研究概览
简要总结
The purpose of this pilot study is to evaluate Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET) as an imaging modality to diagnose and risk stratify subclinical, imaging negative ICI-myocarditis, and to determine whether subclinical ICI-induced myocarditis is a distinct and clinically relevant entity with a risk of progression to fulminant myocarditis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years at the time of signing informed consent
- •Any solid or hematologic malignancy undergoing treatment with ICI (either as a single agent or in combination with others)
- •Ambulatory and able to complete a 48-72 hour high fat and low carbohydrate diet with 18 hours fasting (PET diet), 18F-FDG PET/CT scanning, as well as 13N-ammonia PET-CT myocardial perfusion imaging (part of the routine protocol of the investigation). These two studies will be done as part of the same imaging set.
- •Willing to return to Mayo Clinic for ongoing follow-up
- •Left ventricular ejection fraction (LVEF) ≥45%
- •Cardiac MRI (CMR) without conclusive evidence of inflammation, coronary assessment available (either via cardiac computed tomography angiography, CCTA, or via coronary angiogram) Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
排除标准
- •Fulminant myocarditis requiring steroid therapy
- •CMR with definitive evidence of myocarditis
- •Clinical presentation consistent with acute coronary syndrome (wall motion abnormalities consistent with a specific coronary distribution, coronary angiogram with a culprit lesion identified, patients requiring revascularization either with percutaneous coronary interventions or coronary artery bypass grafting).
- •Patients unable to provide informed consent
- •Patients unable to complete the diet preparation protocol
- •Pregnancy (all women of child-bearing age and potential will have a negative pregnancy test within 48 hours of the PET/CT at screen and 6-month visit)
- •Breastfeeding
结局指标
主要结局
Presennce of inflammation or scarring
时间窗: Baseline; Up to 7 months
Assessed by reviewing 18F-FDG PET/CT imaging for presence of inflammation, progression/regression of inflammation or scarring.
次要结局
- Cardiovascular Intensive Care Unit (CICU) Level of Care Days(Up to 2 years)
- Incidence of hospitalization(Up to 2 years)
- Incidence of arrhythmias(Up to 2 years)
研究者
研究点 (2)
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