Differentiating Radionecrosis From Tumour Progression Using Hybrid FLT-PET/MRI in Patients With Brain Metastases Treated With Stereotactic Radiosurgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Radionecrosis (in patients who have previously received SRS Treatment for BrM)
研究概览
简要总结
Brain metastasis (BrM) develops in approximately 40% of cancer patients. Stereotactic radiosurgery (SRS) is a form of radiotherapy that delivers high-dose per fraction to individual lesions that is commonly used to treat BrM.
Radionecrosis (RN) is an adverse event that occurs in approximately 10 - 25% of patients 6 - 24 months after treatment with SRS. Tumour progression may also occur due to local failure of treatment. Radionecrosis and tumour progression share very similar clinical features including vomiting, nausea, and focal neurologic findings.
Radionecrosis and tumour progression also share overlapping imaging characteristics. Due to their similarities, physicians need to perform a surgical resection to diagnose the complication. By using a hybrid FLT-PET/MRI scan, the investigators propose that this combination scan will provide robust data with which to differentiate between radionecrosis and tumour progression without the need for surgery. The investigators plan to conduct a single center feasibility study to investigate the potential in differentiating between SRS and tumour progression in patients, including those who may have previously undergone SRS for BrM, who are suspected to have either RN or tumour progression using hybrid FLT-PET/MRI imaging.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Previously treated with SRS for BrM
- •New intracranial lesion with clinical and radiographic findings suspicious for either RN or tumour progression
- •May be planned surgical resection of the lesion in question. The determination that the lesion is appropriate for and may require surgical resection will be made by the multi-disciplinary brain metastasis team. Surgery is preferred but not required. If a patient is planned for surgery, the date does not need to be established and the patient does not need to have consented in order to be eligible for this study, however the imaging procedure will need to occur prior to the date of surgery.
- •A negative serum pregnancy test within the two-week interval immediately prior to PET-MRI imaging for women of child-bearing age
- •Ability to provide written informed concern to participate in the study
排除标准
- •Previous radiotherapy to the intended treatment volume
- •Active malignancy other than sarcoma
- •Inability to remain supine for at least 60 minutes
- •Pregnancy or breast feeding
- •Age <18 years
- •Failure to provide written informed consent
- •Contraindication for MRI as per current institutional guidelines
结局指标
主要结局
Radionecrosis (in patients who have previously received SRS Treatment for BrM)
时间窗: 24 Months
Radionecrosis will be assessed by analyzing hybrid FLT-PET/MRI images.
次要结局
- Tumour Progression (in patients who have previously received SRS Treatment for BrM)(24 Months)