Evaluation of Treatment Response to Trop2 ADC by 68Ga-MY6349 PET/CT in NSCLC
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
- The predictive value of series 68Ga-MY6349 PET/CT in patients with NSCLC who received Trop2-ADC therapy
研究概览
简要总结
To evaluate whether serial 68Ga-MY6349 PET/CT imaging can serve as a noninvasive biomarker to predict the therapeutic efficacy of Trop2-targeted antibody-drug conjugate (Trop2-ADC) therapy in NSCLC patients.
详细描述
Patients diagnosed with metastatic Non-Small Cell Lung Cancer（NSCLC） will undergo 68Ga-MY6349 PET/CT imaging at baseline and after two and/or four cycles of Trop2-ADC therapy. Tumor uptake will be quantified using both maximum standardized uptake value (SUVmax) and mean SUV (SUVmean). Imaging changes will be correlated with treatment response to assess the utility of 68Ga-MY6349 PET/CT as a predictive biomarker.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •adult patients (aged 18 years or order)
- •histologically or cytologically confirmed metastatic NSCLC previously treated with systemic therapy, supported by imaging (e.g. CT, MRI), tumor markers, or pathology reports
- •presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
- •willingness to undergo serial 68Ga-MY6349 PET/CT scans before and during Trop2-ADC therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Ability to provide written informed consent and, where applicable, assent in accordance with the requirements of the Clinical Research Ethics Committee
排除标准
- •Evidence of significantly impaired hepatic or renal function
- •Estimated life expectancy of less than 3 months
结局指标
主要结局
The predictive value of series 68Ga-MY6349 PET/CT in patients with NSCLC who received Trop2-ADC therapy
时间窗: 2025.5-2027.5
For 68Ga-MY6349 PET/CT parameter, the maximum standard uptake value (SUVmax) is measured by defining a region of interest (ROI) around the primary tumor. SUVmax values obtained at baseline and after two and/or four cycles of Trop2-ADC therapy were collected and analyzed in relation to treatment response.
次要结局
- Correlation Between PET Parameters and Survival(2025.5-2027.5)