NCT04246879进行中（未招募）不适用
Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- number of positive MRI sequences along with positive tumor biopsies
研究概览
简要总结
The purpose of this study is to test whether an additional magnetic resonance image (MRI) sequence can improve the ability to distinguish radiation damage from tumor recurrence in participants with brain metastasis who have previously been treated with stereotactic radiosurgery (SRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adult patients, age ≥18
- •Metastatic malignancy with at least 1 brain metastasis previously treated with SRS
- •Patients may have also received whole brain radiation therapy (WBRT) for management of brain metastatic disease but this is not required for study participation
- •Patients must have been diagnosed with a metastatic solid tumor of any histological type except small cell lung cancer (SCLC), or lymphoma.
- •Radiographic progression on post-SRS imaging at previously treated SRS site(s)
- •Must be a candidate for brain surgery as determined by treating neurosurgeon and/or anesthesia team
- •Patients must sign study-specific informed consent prior to study entry
排除标准
- •Poor surgical candidate as determined by treating neurosurgeon and/or anesthesia team
- •Unable to undergo contrasted MRI (e.g. incompatible medical device, inadequate renal function per standard institutional clinical protocol, contrast allergy)
- •Small cell lung cancer (SCLC) or lymphoma histology
研究组 & 干预措施
MRI
Experimental
干预措施: MRI (Other)
结局指标
主要结局
number of positive MRI sequences along with positive tumor biopsies
时间窗: baseline
true tumor will be detected by delayed MRI as determined by biopsy
number of negative MRI sequences along with negative tumor biopsies
时间窗: baseline
absence of tumor will be detected by delayed MRI as determined by biopsy
次要结局
未报告次要终点
研究者
研究点 (2)
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