99mTc-H7ND SPECT/CT Imaging in Non-small Cell Lung Cancer Clinical Application Research in Efficacy Evaluation and Efficacy Prediction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- DCR
研究概览
简要总结
To study the clinical application of 99mTc-H7ND SPECT/CT imaging in the efficacy evaluation and prediction of non-small cell lung cancer (NSCLC)
详细描述
This study was a prospective, controlled, single-center clinical study.
To evaluate the value of 99mTc-H7ND imaging in the evaluation of stable disease in patients with non-small cell lung cancer (NSCLC) assessed by RECIST1.1, and to predict the efficacy of subsequent treatment (second-line treatment).
Patients with NSCLC confirmed by cytology or pathology, who were unable to undergo radical surgery because of recurrence, metastasis, or their own conditions, and who had completed 2-4 cycles of first-line therapy and had RECIST1.1 assessment (SD) were divided into 2 groups:
Experimental group: 99mTc-H7ND SPECT/CT imaging performed Control group: 99mTc-H7ND SPECT/CT imaging was not performed
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 18 to 80 years old;
- •patients with NSCLC confirmed by needle aspiration cytology or surgical pathology, who cannot undergo radical surgery due to recurrence, metastasis or patient's own conditions;
- •Has completed 2-4 cycles of first-line therapy (including chemotherapy, immunotherapy, chemotherapy combined with immunotherapy, chemotherapy combined with targeted therapy, etc.), and has SD assessed by RECIST 1.1 during the same period;
- •Patients had at least one measurable lesion;
- •No local radiotherapy for primary or metastatic lesions within 28 days;
- •ECOG score 0-2;
- •Expected survival time ≥3 months;
- •Voluntarily participate and sign informed consent.
排除标准
- •Women who plan to become pregnant within 6 months, or are pregnant or lactating.
- •Patients with severe brain or bone metastases;
- •Severe anemia and severe liver and kidney damage;
- •Pathological or long-term follow-up results may not be available;
- •The relevant control imaging data and clinical data were not available;
- •Severe illness is difficult to cooperate (such as acute cardiovascular and cerebrovascular events or serious cardiovascular diseases);
- •Received any surgery or invasive treatment or procedure within 4 weeks before enrollment;
- •Cannot tolerate standard second-line therapy or other first-line therapies.
- •Known allergy to 99mTc-H7ND or any of its components; He had a history of severe allergies;
- •Protocol imaging contraindications were present;
- •The investigator considered it inappropriate to participate in the study.
结局指标
主要结局
DCR
时间窗: Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
Comparison of DCR in groups of NSCLC patients with stable disease assessed by RECIST1.1.
次要结局
- PFS(Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment)
- OS(Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment)