[18F]BF3-BPA Injection for PET Imaging Study of Gliomas in the Brain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Complete PET imaging
研究概览
简要总结
In this clinical study, we proposed to perform [18F]BF3-BPA PET imaging in subjects with gliomas, to observe the binding ability and non-specific binding of the tracer to glioma lesions in vivo, and at the same time to evaluate the effectiveness of [18F]BF3-BPA in the diagnosis and differential diagnosis of glioma, and to evaluate the tolerability and safety of the tracer and the imaging method. The efficacy of [18F]BF3-BPA in the diagnosis and differential diagnosis of gliomas will be evaluated, as well as the tolerability and safety of this tracer and imaging method.
This study will provide a new method for in vivo imaging of gliomas and provide a clear and intuitive imaging basis for clinical diagnosis, differential diagnosis and treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with suspicious brain gliomas:
- •Patients diagnosed by the investigator, based on symptoms, course of disease, and MRI of the head, as having a suspected high- or low-grade brain glioma, scheduled for brain tumor resection, and with no contraindications to surgery;
- •No prior and/or current surgery, radiotherapy, or puncture biopsy (other than treatment for symptomatic relief) for brain tumors;
- •No other primary malignant tumor.
- •age ≥ 18 years;
- •Eastern Cooperative Oncology Group (ECOG) 0-2;
- •adequate organ function:
- •Platelet count >100 x 109/L;
- •Urea/urea nitrogen and serum creatinine <1.5 times upper limit of normal (ULN);
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times ULN.
- •Subjects should be fully informed of the content, process and possible risks of the test and voluntarily sign an informed consent form.
排除标准
- •Subjects meeting any of the following criteria will be excluded from the study:
- •Severe allergic reaction to any of the drugs or their components in this trial;
- •Those who cannot tolerate or are contraindicated to undergo MRI and PET;
- •Those who cannot accept or tolerate blood sample collection;
- •Those who are unable to use effective contraception from the date of signing the informed consent to 3 months after the administration of the drug;
- •pregnant or lactating women or those with positive blood pregnancy test results;
- •Those who have participated in other interventional clinical trials prior to the date of informed consent and are within 5 half-lives of the trial drug, or are participating in other interventional clinical trials;
结局指标
主要结局
Complete PET imaging
时间窗: 90mins from time of injection
To evaluate the biodistribution characteristics (SUVmax, SUVmean) of PET imaging with different doses of \[18F\]BF3-BPA in brain tumor/normal brain tissues of patients with suspected gliomas, and to obtain the optimal imaging time and optimal dose of \[18F\]BF3-BPA PET imaging in patients with suspected gliomas.
次要结局
未报告次要终点