Study on the Diagnosis of Ground-glass Lung Cancer by Microwave Ablation Combined With Puncture Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Local contral rate
研究概览
简要总结
This study is a multicenter study. It plans to screen 200 patients with pulmonary nodule lesions with ground glass as the main body, take CT thin-layer scanning 3D reconstruction, apply AI and fragment omics technology to evaluate the risk of malignant transformation of pulmonary nodules, and use microwave ablation to treat pulmonary nodules and combine intraoperative rapid pathology technology to determine the nature of puncture tissue and the degree of ablation, and then explore the optimal ablation time and ablation power.
详细描述
Combining AI and fragmentomics technology, this study enrolled 200 patients with ground-glass lung cancer for comprehensive evaluation. By collecting detailed characteristic data of ground-glass lung cancer, including nodule diameter, average CT value, solid component ratio (CTR), nodule morphology and other related signs, CT imaging and AI technology, and fragmentomics technology were used for comprehensive analysis to form a set of joint strategies to efficiently screen and diagnose patients with early lung cancer.
Microwave ablation is used to treat lung nodules, and intraoperative rapid pathology technology is used to determine the nature of the punctured tissue and the degree of ablation (observing pathological changes in the lesion area, including cancer cell death and fibrosis of the lesion tissue), determine whether the lesion has been completely ablated, or whether there are residual active cancer cells, and then explore the optimal ablation time and ablation power.
Finally, long-term follow-up of patients after microwave ablation, including collection of intraoperative/postoperative complication data, regular CT review, evaluation of treatment effect, monitoring for recurrence, and improving individualized treatment plans for patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤ 75 years;
- •GGN patients with the maximum axial diameter of the lesion in the lung window ≤ 3 cm;
- •Refusing radical surgery or being unable to tolerate surgical treatment;
- •Normal coagulation function, platelet count ≥ 60 × 109 /L;
- •ECOG score ≤ 2 points;
排除标准
- •Patients with the maximum axial diameter of the lesion in the lung window greater than 3 cm
- •Platelets <50×109 /L
- •Patients with severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term
- •Severe chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis and pulmonary hypertension
- •Patients whose anticoagulant therapy or antiplatelet drugs have been discontinued for less than 5 days before ablation
- •Patients with severe heart, liver, kidney and brain dysfunction
- •Patients with severe anemia, dehydration and cachexia that cannot be corrected or improved in the short term
- •Patients with an estimated survival period of less than 6 months
结局指标
主要结局
Local contral rate
时间窗: up to 36 months
LCR is the rate of CR, PR plus SD
Overall Survival
时间窗: up to 36 months
Defined as the time from randomization to death from any cause.
Recurrence-free survival
时间窗: up to 36 months
It estimates the recurrence-free rate of patients who have already survived, with no history of metastasis, a certain period of time.
次要结局
- Detection rate(up to 36 months)
研究者
LiuMingyang
Director
Beidahuang Industry Group General Hospital