NCT05864794招募中不适用
ValUe of Screening MRI Brain in Patients With Newly Diagnosed Stage IV Non-oncogene Addicted Non-small Cell Lung CANcer - The VULCAN Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Clinical value of the MRI
研究概览
简要总结
Patients with newly diagnosed stage IV non-oncogene addicted NSCLC, who are fit for systemic treatment and don't have any symptoms of brain disease will undergo an MRI of the brain to screen for brain disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Histologically or cytologically confirmed stage IV metastatic NSCLC, not amenable to curative treatment.
- •Fit for systemic treatment (PS 0-2) according to standard of care.
- •No symptoms of brain disease disease assessed according to standard clinical care by the thoracic oncologist.
排除标准
- •Prior/concomitant therapy for stage IV disease.
- •Oncogenic diver mutation (e.g. EGFR, ALK, ROS1, RET, MET, and BRAF) with approved targeted treatment.
- •Contraindications for MRI scan with contrast as per standard of care protocol of the institution.
研究组 & 干预措施
Screening population
Experimental
Patients with newly diagnosed stage IV non-oncogene addicted NSCLC, who are fit for systemic treatment and don't have any symptoms of brain disease.
干预措施: MRI (Diagnostic Test)
结局指标
主要结局
Clinical value of the MRI
时间窗: up to 6 months after the MRI
Clinical value of the MRI evaluated by the treating thoracic oncologist and assessed by questionnaires completed on three timepoints.
次要结局
未报告次要终点
研究者
研究点 (4)
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