18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- to distinguish radiation necrosis from progressive tumor
研究概览
简要总结
The main purpose of this study is to determine the distribution of 18F Fluorocholine (18F-FCH) in the brain which can help distinguishing radiation-induced scarring from tumor regrowth. In addition, the study will measure levels of 18F-FCH in the blood and (if applicable) in the brain lesion tissue that is removed as part of the planned brain surgery.
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
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient and/or guardian is able to provide written informed consent prior to study registration
- •Age ≥ 21 years old
- •Evolving brain lesions post SRS requiring neurosurgical resection (whether for symptomatic control or to establish pathology)
排除标准
- •Inability to undergo a MRI or PET scan (e.g., claustrophobia or metal implant)
- •Pregnant or nursing female
- •Unable to cooperate for PET/CT
研究组 & 干预措施
pts with brain mets going for surgery
This study will enroll patients with brain metastases that are evolving after SRS who are scheduled to undergo surgical resection. Eligible patients will undergo an 18F-FCH PET study 1-to-7 days pre-operatively. Although no toxicity has been previously reported following 18F-FCH administration, patients will be contacted 1-3 days after their scan and asked whether they experienced any adverse effects. The patients who have a positive 18F-FCH PET study (in which there is visible focal "hot spots" (a focus of lesion/normal white matter ratio >1.4) of 18F-FCH) will undergo further evaluation and be administered a second administration oflower activity 18F-FCH at the time of surgery. The purpose of the second 18F-FCH administration in the operating room is to further elucidate the tissue distribution of 18F-FCH radioactivity with respect to the histopathology of the surgically resected tissue.
干预措施: 18F-FCH PET Scan (Procedure)
结局指标
主要结局
to distinguish radiation necrosis from progressive tumor
时间窗: 1 year
by comparing the PET imaging results to the surgical pathology
次要结局
未报告次要终点
