NCT07105982尚未招募不适用
Clinical Application of a Novel Radiolabeled Translocator Protein (TSPO) Targeted Small Molecular Probe in Inflammation Imaging of Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
- 主要终点
- SUVmax of lesion uptake value
研究概览
简要总结
Evaluate the clinical application value of the novel radiolabeled TSPO-targeted molecular probe Gallium [68Ga]-DOTA-HK-011 for inflammation imaging associated with acute myocardial infarction.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers, patients, or their legal representatives must sign the informed consent form and be able to cooperate with the PET-MR examination by lying flat for more than 30 minutes and maintaining a stable position.
- •No gender restrictions; age between 18 and 75 years, inclusive.
- •Patients must meet the diagnostic criteria for acute myocardial infarction (AMI), such as elevated myocardial enzyme spectrum, dynamic changes in electrocardiogram, or confirmation by coronary angiography.
- •Patients who are 7 to 10 days post-onset of acute myocardial infarction.
- •Renal GFR > 50 ml/min; ERPF > 280 ml/min; platelet count (PLT) > 75,000/μL; white blood cells (WBC) > 3,000/μL; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than three times the upper limit of normal.
排除标准
- •Individuals with a history of allergy to similar drugs (drugs with similar chemical or biological components to TSPO), a history of allergies, or currently suffering from allergic diseases.
- •Use of anti-inflammatory drugs (such as corticosteroids or immunosuppressants) within the last 14 days, which may affect inflammation imaging.
- •Hemodynamically unstable conditions (such as cardiogenic shock or severe arrhythmias); Recent cerebral hemorrhage or severe bleeding tendency within the last 30 days.
- •Red blood cell count (RBC) < 4×10^12/L, white blood cell count (WBC) < 3×10^9/L, hemoglobin less than 110 g/L, platelet count (PLT) < 75×10^9/L.
- •Significant abnormal liver or kidney function, with glomerular filtration rate (GFR) less than 50 ml/min.
- •Presence of ferromagnetic metals implanted in the body (such as cardiac pacemakers, artificial heart valves, metal stents, etc.).
- •Claustrophobia or inability to tolerate prolonged examinations.
- •Presence of severe acute concomitant diseases or severe refractory mental disorders.
- •Pregnant or breastfeeding women (pregnancy defined as a positive urine pregnancy test).
- •Patients whose physical condition contraindicates radioactive examinations, such as severe cardiopulmonary insufficiency or other conditions deemed unsuitable by the investigator.
- •Other circumstances deemed unsuitable for participation in the trial by the researcher.
结局指标
主要结局
SUVmax of lesion uptake value
时间窗: Time Frame: 60min after administration
次要结局
未报告次要终点
研究者
Feng Wang
Chief physician
Nanjing First Hospital, Nanjing Medical University
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