NCT07105956尚未招募不适用
Clinical Application of a Novel Radiolabeled Translocator Protein (TSPO) Targeted Small Molecular Probe in Neuroinflammation Imaging of Alzheimer's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
- 试验地点
- 1
- 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 in neuroinflammation imaging of Alzheimer's disease.
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
- •Volunteer for the trial, with the patient or their legal guardian signing the informed consent form.
- •Volunteers are not limited by gender, and the age range is from 18 to 75 years old, including both ends.
- •The patient is diagnosed with Alzheimer's disease (AD), supported by a positive amyloid PET scan.
- •The patient has completed Tau PET scan.
排除标准
- •Individuals with a history of allergy to drugs chemically or biologically similar to TSPO, a history of atopy, or currently suffering from allergic diseases.
- •Use of anti-inflammatory drugs, including corticosteroids and immunosuppressants, within the past 14 days, which may interfere with the accuracy of inflammation imaging.
- •Presence of other coexisting neurological diseases, such as stroke, Parkinson's disease, brain tumors, or mental disorders, including depressive disorder and schizophrenia.
- •Severe cardiac, pulmonary, hepatic, or renal dysfunction, or uncontrolled systemic diseases;
- •Presence of metal implants contraindicated for MRI, including but not limited to cardiac pacemakers, artificial heart valves, and metal stents.
- •Claustrophobia or inability to tolerate prolonged examinations.
- •Pregnant women (defined as those with a positive urine pregnancy test) or breastfeeding women.
- •Patients whose physical condition is unsuitable for radioactive tracer-based imaging examinations.
- •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: 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
研究点 (1)
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