Imaging Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis (IRRAS-BM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
This trial uses multi-parametric magnetic resonance imaging (MRI) to develop and validate imaging risk score to predict radiation necrosis in participants with brain metastasis treated with radiation therapy. Diagnostic procedures, such as multi-parametric magnetic resonance imaging (MRI), may improve the ability to diagnose radiation necrosis early and help establish treatment strategies.
详细描述
PRIMARY OBJECTIVE:
I. To develop an imaging risk score for recurrence after stereotactic radiosurgery (SRS) in brain metastasis using multiparametric MRI.
II. To validate the imaging risk score in retrospective external validation and prospective internal validation test set.
SECONDARY OBJECTIVE:
I. To predict radiation necrosis using imaging risk score.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients who underwent stereotactic radiosurgery (SRS, gamma-knife radiosurgery or cyberknife radiosurgery) for brain metastases
- •Patients with lesions eligible for SRS :
- •One to ten newly diagnosed brain metastases
- •Patients without acute neurological symptom
- •Patients with a Karnofsky performance status score of 70 or higher
- •Patients who underwent brain MRI within 1 month of enrollment
- •Patients with measurable enhancing lesions on MRI.
- •Patients who have available reference standard (second-look surgery for recurrence) or available follow up imaging for clinic-radiologic reference standard.
- •A longest diameter > 1.5 cm for tumor habitat analysis.
- •Exclusion criteria:
- •Patients who have undergone prior brain surgery, SRS, or whole-brain radiation therapy.
- •Patients who are diagnosed with leukemia, lymphoma, germ-cell tumor, small-cell lung cancer, leptomeningeal disease, or unknown primary tumor.
- •Patients with age < 18 years.
- •Patients without baseline MRI.
- •Patients with nonmeasurable enhancing lesions on MRI : all other lesions, including lesions with longest dimension < 10 mm, lesions with borders that cannot be reproducibly measured, dural metastases, bony skull metastases, and leptomeningeal disease.
排除标准
- 未提供
结局指标
主要结局
Time to progression
时间窗: up to 24 months
The time from the date of SRS for brain metastasis until the date of progression.
次要结局
- Response rate(up to 24 months)
- Occurence rate of radiation necrosis(12 months)
- Tumor habitat analysis(Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months)
- Imaging risk score for recurrence(Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months)
研究者
Ho Sung Kim
Professor
Asan Medical Center