Evaluation of Brain Metastases Treated With Stereotactic Radiotherapy Using Dynamic [18F]FDG PET
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Diagnostic accuracy of dynamic PET
研究概览
简要总结
The purpose of this study is to evaluate the clinical usefulness of dynamic [18F]FDG PET imaging in assessing brain metastasis post stereotactic radiotherapy to separate true progression from the treatment-related changes.
详细描述
After being informed about the study and potential risk, all participants giving written informed consent will be screened to determine if participant being referred fits eligibility criteria for the study, under of the supervision of the radiation oncologist. If a participant agrees to participate in this study, they will receive three additional imaging sessions (the dynamic PET scan). The first session will occur prior to starting treatment; the second session will occur at about 10 weeks post treatment; the third session will occur at first concern of progression at treated lesions or 12 months post-treatment, whichever comes earlier. These scans will be scheduled in addition to the participant's regular follow-up scans and appointments.
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
- •Age 18 or older.
- •Willing and able to provide consent.
- •Life expectancy ≥12 months.
- •Creatinine clearance ≥30 ml/min within 28 days prior to registration.
- •At the discretion of the treating oncologist, it is believed that at least 1 lesion (or resection cavity) is best managed with SRS/SFR
排除标准
- •Pregnant or nursing women.
- •Men or women of childbearing potential who are unwilling to employ adequate contraception.
- •Inability to complete a brain MRI.
- •Known allergy to gadolinium.
- •Inability to complete a PET scan.
- •Uncontrolled diabetes mellitus.
- •Primary germ cell tumour, primary CNS tumour, or lymphoma
- •SRS/FSRT is no longer indicated for any BMs
- •Must be able to read and write English
结局指标
主要结局
Diagnostic accuracy of dynamic PET
时间窗: 12-month follow-up.
Diagnostic accuracy will be calculated and compared based on the index lesion.
次要结局
- Cost-effectiveness analysis(24-month follow-up)
- Clinical outcomes(24-month follow-up)
- Diagnostic imaging outcomes(24-month follow-up)
研究者
Melody Qu
Radiation Oncologist
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's