A Pilot Study of Dual Time Point FDG PET MR Imaging Optimization for the Evaluation of Brain Metastasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- assess the optimal fludeoxyglucose F-18 (fluorodeoxyglucose) positron emission tomography (FDG PET) imaging time post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma
研究概览
简要总结
This phase IV trial studies how well delaying positron emission tomography (PET)/magnetic resonance imaging (MRI) scan after injection of fluorodeoxyglucose (FDG) can improve the imaging of patients with cancer that has spread to brain (brain metastases). FDG is a type of imaging agent that doctors use to help "see" the images on a scan more clearly. Delaying PET/MRI scan after injecting FDG may improve how well doctors can tell the difference between healthy and unhealthy tissue.
详细描述
PRIMARY OBJECTIVE:
I. To assess the optimal fludeoxyglucose F-18 (fluorodeoxyglucose) positron emission tomography (FDG PET) imaging time post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma (measured as lesion/background [L/B] ratio) in patients with brain metastasis.
SECONDARY OBJECTIVE:
I. To identify genotypic factors in FDG tumor metabolism derived from metrics, including maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), total lesion glycolysis (TLG), mean tumor volume (MTV), and L/B ratio.
EXPLORATORY OBJECTIVES:
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
- •Pre-treatment adult patients with any solid organ metastasis and at least three intraaxial brain metastases including at least one enhancing > 10 mm lesion
- •Rim or solid enhancing lesion(s) WITH a history of non-central nervous system (CNS) pathologic proven metastatic disease will be considered as a consensus between the referring radiation oncologist or neurosurgeon and a neuroradiology
- •Planned surgery or radiation to the metastases
- •Ability to undergo PET magnetic resonance (MR) examination
排除标准
- •Known allergy to FDG or gadolinium based contrast agents
- •History of impaired renal function (glomerular filtration rate [GFR] < 30)
- •Pregnant women are excluded
研究组 & 干预措施
Diagnostic (fludeoxyglucose F-18, PET/MRI)
Patients receive fludeoxyglucose F-18 IV over approximately 1 minute and undergo a PET/MRI scan over 70 minutes. Within 5 hours of receiving fludeoxyglucose F-18, patients undergo a repeat PET/MRI scan over 30 minutes. Scans take place within 2 weeks before scheduled surgery and within 4-6 weeks after radiation treatment.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic (fludeoxyglucose F-18, PET/MRI)
Patients receive fludeoxyglucose F-18 IV over approximately 1 minute and undergo a PET/MRI scan over 70 minutes. Within 5 hours of receiving fludeoxyglucose F-18, patients undergo a repeat PET/MRI scan over 30 minutes. Scans take place within 2 weeks before scheduled surgery and within 4-6 weeks after radiation treatment.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (fludeoxyglucose F-18, PET/MRI)
Patients receive fludeoxyglucose F-18 IV over approximately 1 minute and undergo a PET/MRI scan over 70 minutes. Within 5 hours of receiving fludeoxyglucose F-18, patients undergo a repeat PET/MRI scan over 30 minutes. Scans take place within 2 weeks before scheduled surgery and within 4-6 weeks after radiation treatment.
干预措施: Fludeoxyglucose F-18 (Radiation)
结局指标
主要结局
assess the optimal fludeoxyglucose F-18 (fluorodeoxyglucose) positron emission tomography (FDG PET) imaging time post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma
时间窗: through study completion, an average of a year
次要结局
未报告次要终点