NCT06301100招募中不适用
Single-center, Prospective Study on the Identification and Delineation of Brain and Lung Tumors and At-Risk Organs, and Functional Testing of Surrounding Tissues Based on Dual-Energy CT
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年4月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- DICE value
研究概览
简要总结
This study explored the feasibility of dual-energy CT in head and lung tumors. Dual-energy CT can achieve quantitative CT imaging based on traditional imaging by dual-energy spectral imaging, and enhance the clarity of head and lung tumors. In this study, we will prospectively explore the image accuracy and delineation accuracy of dual energy CT in radiotherapy to verify whether dual energy CT performs better with conventional CT.
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
- •Voluntarily participate in and sign the informed consent in person.
- •Over 18 years old, gender unlimited;
- •After imaging diagnosis of primary lung cancer or space-occupying lung lesions with oligometastases, MDT decided to treat SBRT
- •Clinical stage IA-IV (cT1-4N1-3M0-1);
- •No serious abnormality of blood system, heart, lung, liver, kidney function and immune deficiency;
- •Coagulation function: activated partial thromboplastin time (APTT) < the upper limit of normal 10 seconds, prothrombin time (PT) < the upper limit of normal 3 seconds, plasma fibrinogen 2-4g/L;
- •Hemoglobin ≥100g/L, WBC≥4×109/L, neutrophils ≥1.5×109/L, platelets ≥100×109/L
- •Bilirubin < 1.5 times the upper limit of normal value; Glutamic oxalic aminotransferase (ALT) & Glutamic pyruvic aminotransferase (AST) ≤1.5 times the upper limit of normal value;
- •Serum creatinine ≤1.5 times the upper limit of normal value;
- •The willingness of men or women of childbearing age to use contraception in the trial;
- •Physical condition score ECOG level 0 ~ 2;
- •Expected survival >3 months;13, Can acquire MRI scanning
排除标准
- •Patients could not tolerate or were unwilling to undergo CT examination;
- •The primary lesion has undergone surgery or radiotherapy or chemotherapy or targeted or immunotherapy;
- •Subjects who have received other drug trials within the last 1 month;
- •People with severe allergic history or idiosyncrasies;
- •Patients with a history of severe lung or heart disease;
- •Severe comorbidities, such as uncontrolled hypertension, heart failure, etc.;
- •Pregnant or lactating women;
- •Previous history of malignant tumor;
- •Refusal or inability to sign informed consent to participate in the trial;
- •Currently or planning to participate in other clinical trials; 11,Can not acquire MRI scanning
结局指标
主要结局
DICE value
时间窗: 2023.4-2024.12
The contouring accuracy
次要结局
未报告次要终点
研究者
研究点 (1)
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