NCT02311556已完成1 期
Assessment of Early Treatment Response of Brain Metastases After Gamma-Knife Radiosurgery Using Dynamic Susceptibility-weighted Contrast-enhanced Perfusion Magnetic Resonance Imaging
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Time to local progression of each treated and evaluable brain metastasis
研究概览
简要总结
This study is designed to evaluate whether advanced magnetic resonance imaging (MRI) techniques such as dynamic susceptibility-weighted contrast-enhanced perfusion MRI may be used to predict treatment response of brain metastasis after radiosurgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have newly diagnosed brain metastases visible on brain MRI. A biopsy of the lesion is not required as long as the patient has a biopsy-proven malignancy elsewhere and a clinician deems the lesion to be metastatic.
- •At least one brain metastasis must be ≥ 1cm to allow adequate quantitative imaging measurement for DSC-PMR.
- •Patient must be clinically eligible for and elect to be treated with GK alone without WBRT.
- •Patient must be ≥ 18 years of age.
- •Patient must have Karnofsky Performance Status (KPS) of at least 60
- •Patient may be part of other clinical trials (as long as no other local treatments beyond GK such as WBRT or other local therapy are indicated to the brain) or imaging studies.
- •Patient or legally authorized representative must be able to understand and willing to sign a written informed consent document.
排除标准
- •Patient must not have any medical contraindications to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).
- •Patient must not be pregnant or breastfeeding.
- •Patient must not have an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m
- •Patient must not have melanoma.
- •Patient must not have hemorrhagic lesions.
结局指标
主要结局
Time to local progression of each treated and evaluable brain metastasis
时间窗: At time of radiosurgery and after radiosurgery (approximately 1 week)
Tumor perfusion on DSC-PMR will be used as predictor for time to local tumor progression.
次要结局
- Radiation necrosis(Up to 1 year)
- Complete response(Up to 1 year)
- Elsewhere brain failure(Up to 1 year)
- Clinical deterioration(Up to 1 year)
研究者
研究点 (2)
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