跳至主要内容
临床试验/NCT02037945
NCT02037945已完成不适用

18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases

Memorial Sloan Kettering Cancer Center1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

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

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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