Construction and Application of an IDH Mutation-Targeted PET/MRI Imaging Framework for Precision Diagnosis of Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Diagnostic efficacy, survival analysis
研究概览
简要总结
Glioma is the most common primary intracranial tumor in adults, with high-grade gliomas accounting for more than 50% of all gliomas and having the highest mortality rate. The molecular characteristics of gliomas are closely associated with the selection of treatment regimens, therapeutic efficacy, and patient prognosis. Mutations in isocitrate dehydrogenase (IDH) are an important diagnostic marker for diffuse gliomas and a key component in distinguishing and defining glioma subtypes. Furthermore, the advent of IDH-targeting inhibitors has brought hope to patients with IDH-mutant gliomas. Therefore, accurately assessing the IDH mutation status of gliomas is a prerequisite and key to precision diagnosis, targeted therapy, and prognostic evaluation. This study explores the application value of targeted IDH PET/MRI imaging in glioma subtype diagnosis, tumor grading, and prognostic evaluation. It aims to establish a non-invasive in vivo tracing technology platform and evaluation system for accurately assessing glioma IDH mutation status, subtype diagnosis, and prognostic evaluation. This will provide a basis for the precise diagnosis of gliomas, the selection of targeted treatment regimens, and prognostic assessment, and promote future research and development of therapeutic drugs using labeled therapeutic radionuclides.
详细描述
- Clinical and biological data: The records include all patients' general clinical information, disease course, and other imaging findings.
- PET image analysis: Record and assess lesion location, size, maximum standardized uptake (SUVmax), and target-to-species ratio (TBR), where the TBR value is calculated by dividing the SUVmax of the lesion by the background SUVmean.
- Pathological analysis: Hematoxylin and eosin staining and immunohistochemical analyses will be performed. Immunohistochemical analysis will be used to investigate the status of isocitrate dehydrogenase (IDH).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient ≥ 18 years of age at the time of consent;
- •Patients with suspected, newly diagnosed, or previously treated gliomas;
- •Provided written informed consent authorisation before participating in the study.
排除标准
- •Pregnancy or lactation;
- •MRI contraindications, not limited to cardiac implantable electronic devices and claustrophobia;
- •Participants with radiation exposure exceeding 50 mSv in the past year.
结局指标
主要结局
Diagnostic efficacy, survival analysis
时间窗: Completed within half year after end of the study
sensitivity, specificity, accuracy, positive and negative predictive values, ROC curve analysis,
次要结局
未报告次要终点
研究者
Xiao Chen
Director of Nuclear Medicine Department
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University