A Prospective Study to Explore the Performance and Efficacy of 99mTc-CNDG Injection in Malignant Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Compared with 18F-FDG PET/CT or CECT
研究概览
简要总结
Currently, 18F-fluorodeoxyglucose (18F-FDG) is the most widely used tumor imaging agent in clinical practice. However, the production of 18F requires accelerators and is associated with relatively high diagnostic costs, which to some extent limits its widespread clinical application. In comparison to Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT) devices are more abundant and offer lower diagnostic expenses. With the utilization of Cadmium Zinc Telluride (CZT) crystals in SPECT and advancements in image reconstruction techniques, the resolution and sensitivity of SPECT is continually improving. Therefore, the development of a simplified and cost-effective novel SPECT tumor imaging agent holds significant practical significance. This study involved the design and synthesis of a glucose-derived ligand with a linker containing seven methylene units and an isonitrile group (CN7DG). The CN7DG ligand was labeled with 99mTc to prepare a more lipophilic 99mTc-CN7DG complex, aiming to investigate a novel SPECT imaging agent for tumor imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years old
- •Patients diagnosed with malignant glioma, colorectal cancer, pancreatic cancer, lung cancer, breast cancer, or other malignant tumors through imaging techniques such as MRI, CT, and ultrasound, and who are scheduled for surgical resection or biopsy
- •Solid tumor sizes greater than 2cm
- •Voluntarily agree to participate and sign an informed consent form
- •Can provide complete surgical records, pathological results, control data, and clinical follow-up results
排除标准
- •Pre-treatment such as chemotherapy and targeted therapy has been administered
- •Pregnancy and breastfeeding
- •Claustrophobia
- •The condition is severe and difficult to cooperate with
- •Unable to obtain relevant control imaging data and clinical information
结局指标
主要结局
Compared with 18F-FDG PET/CT or CECT
时间窗: through study completion, an average of 1 year
The number of lesions detected by 99mTc-CNDG SPECT/CT was compared with 18F-FDG PET/CT or CECT
Lesions detected by 99mTc-CNDG SPECT/CT
时间窗: through study completion, an average of 1 year
The number of target lesions was calculated by 99mTc-CNDG SPECT/CT
Uptake value of 99mTc-CNDG in malignant tumors
时间窗: through study completion, an average of 1 year
The uptake value was measured in the malignant lesions on 99mTc-CNDG SPECT/CT.
次要结局
未报告次要终点