NCT07106008尚未招募不适用
Clinical Application of a Novel Radiolabeled Translocator Protein (TSPO) Targeted Small Molecular Probe in Neuroinflammation Imaging of Glioma
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 in inflammation imaging of glioma.
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
- •Voluntary subjects, patients, or their legal representatives must sign the informed consent form.
- •There are no restrictions on the gender of volunteers; age must be between 18 and 75 years, inclusive.
- •Other imaging examination methods (e.g., CT, MRI) show the presence of intracranial lesions.
- •Patients with brain glioma who are scheduled for surgery or biopsy that will provide final pathological results.
- •Patients must have a kidney GFR > 50 mL/min, ERPF > 280 mL/min, platelet count (PLT) > 75,000/μL, white blood cell count (WBC) > 3,000/μL, and alanine aminotransferase (ALT) and asparta.
排除标准
- •Individuals with a history of allergy to drugs with similar chemical or biological components to TSPO, a history of atopy, or currently suffering from allergic diseases.
- •Individuals currently participating in other drug clinical studies, or who have previously participated in any drug (excluding vitamins and minerals) clinical studies.
- •Individuals with other difficult-to-control clinical conditions, such as HIV infection, hepatitis C virus infection, active hepatitis B, other severe chronic infections, or serious mental, neurological, cardiovascular, respiratory, or other systemic diseases.
- •Red blood cell count (RBC) < 4×10^12/L, white blood cell count (WBC) < 3×10^9/L, hemoglobin < 110 g/L, platelet count (PLT) < 75×10^9/L.
- •Significant liver and kidney function abnormalities, glomerular filtration rate (GFR) < 50 ml/min.
- •Tumor burden involving more than 50% of the affected organ, or significant spinal cord compression.
- •Expected survival time less than six months, or having received chemotherapy within the past six months.
- •Individuals with severe acute comorbidities or severe refractory mental disorders.
- •Pregnant or breastfeeding women (pregnancy defined as a positive urine pregnancy test).
- •Individuals whose physical condition is unsuitable for radioactive examination.
- •Other circumstances deemed unsuitable for participation in the trial by the investigator.
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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