NCT06234319招募中不适用
Clinical Study on CXCR4 PET/MRI Targeted Integrated Imaging for Grading Diagnosis, Molecular Typing, and Prognostic Evaluation of Brain Glioma
Xiao Chen1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Standardised uptake values
研究概览
简要总结
This project intends to evaluate the role of C-X-C chemokine receptor type 4 (CXCR4) targeted PET/MRI integrated imaging in the grading and molecular typing of brain gliomas, using primary glioma patients as the research subjects and post-operative histopathological analysis as the reference, and to establish an evaluation model for the prognosis of primary glioma patients.
详细描述
- PET/MRI Scan: Image acquisition was completed 15 days before surgery. CXCR4 contrast agent was injected at 6.5 MBq/kg based on body mass, with no drug extravasation, and imaging was performed after 60 minutes of quiet rest. All subjects were scanned in a supine position on a single bed of the Signa™ 3.0T scanner (GE Healthcare Systems), using a 3.0T gem HNU head coil with a scanning field of view focused on the head. PET acquisition lasted for 20 minutes and was reconstructed using OSEM. Simultaneous MRI acquisition included MR-based attenuation correction (MRAC) - zero echo time pulse sequence (ZTE), as well as structural and functional MRI sequences (T1WI, T2WI, FLAIR, DWI, MRS, DSC, T1-CE). Image fusion was performed on a GE post-processing workstation.
- Image Analysis and Observation Indicators: PET/MRI images were independently reviewed and processed by two experienced neuroradiologists. Using IKT-SNAP software, target lesion VOIs were outlined based on FLAIR and T1-CE sequences. VOI delineation on the FLAIR sequence included solid tumor components, necrotic areas, and surrounding abnormal FLAIR signal regions. VOI delineation on the T1-CE sequence included enhanced solid components, non-enhanced solid components, and necrotic areas. MRI parameters (diffusion-weighted imaging parameters: ADC; perfusion imaging parameters: CBF, CBV, MTT, TTP; spectroscopic parameters: NAA, Cho, Cr, Lac, NAA/Cr, Cho/Cr) and PET parameters (SUVmax, SUVmean, SUVpeak, CXCR4 metabolic volume, TBR) were measured throughout the tumor and corresponding regions.
- Pathological Analysis: Slices containing no less than 25% tumor tissue were used, with each slice having a thickness of 4um. HE, CD34, and CXCR4 immunohistochemical staining were performed separately. Two senior pathologists reviewed the slides using a double-blind method. IDH mutation status and 1p/19q deletion status were determined by the pathology department.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with primary glioma based on clinical, imaging, and histopathological criteria;
- •The patient is at least 18 years old;
- •Participate in CXCR4 PET/MRI imaging within 15 days before surgery;
- •Surgical resection of glioma lesion tissue can be used for pathological analysis;
- •The patient voluntarily participates and signs the informed consent form.
排除标准
- •Pregnant or breastfeeding patients;
- •The image quality of the imaging is poor and cannot be used for diagnosis and evaluation;
- •Molecular typing was not determined by histologic examination;
- •patients with claustrophobia;
- •Patients who are allergic to radioactive tracers and MRI contrast agents, and patients with renal insufficiency.
结局指标
主要结局
Standardised uptake values
时间窗: completed within one week after the PET/MRI examination
Standardised uptake values of suspected glioma disease in CXCR4 PET/MRI imaging
expression of CXCR4
时间窗: completed within one week after surgery
Immunohistochemical evaluation of the expression of CXCR4 in postoperative tumor tissue
expression of CD34
时间窗: completed within one week after surgery
Immunohistochemical evaluation of the expression of CD34 in postoperative tumor tissue
次要结局
- SUV and IDH mutation status(through study completion, an average of 1 year)
- SUV and histological grading of glioma(through study completion, an average of 1 year)
- CXCR4 expression and histological grading of glioma(through study completion, an average of 1 year)
- SUV and 1p/19q deletion status(through study completion, an average of 1 year)
研究者
Xiao Chen
Director of Nuclear Medicine Department
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
研究点 (1)
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