Multiparametric Imaging in Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Quantitative measure of C11 Methionine uptake
研究概览
简要总结
Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography imaging with intravenously injected C11 Methionine to detect viable lesions.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Multiple Myeloma with symptomatic bone or soft tissue disease
- •Eastern Cooperative Oncology Group status 0 to 2
- •Life expectance >= 12 weeks
- •Ability to understand and willingness to sign informed consent
- •Tissue sampling with genotype data planned within 3 months of C11 positron emission tomography (PET) imaging
排除标准
- •Pregnant or breast feeding
- •Claustrophobic reactions and unable to lie still on a bed inside the PET scanner for 60 minutes
- •Research related radiation exposure exceeding 50 millisieverts
研究组 & 干预措施
Intervention
C11 Methionine positron emission tomography (PET/CT) studies will be performed as hybrid PET/CT examinations for attenuation correction and lesion localization. A bolus of 10 millicuries of C11 Methionine will be injected intravenously. Approximately 60 minutes following tracer injection, the patient will be positioned on a Siemens Biograph PET/CT scanner. A low milliampere CT of from the mid skull to mid thigh will be acquired first with while the patient is free breathing. PET will be acquired at 3 minutes per bed position using the 3D mode, approximately 6-7 bed positions. C11 Methionine PET/CT imaging will take less than 60 minutes.
干预措施: C11 Methionine positron emission tomography (Drug)
结局指标
主要结局
Quantitative measure of C11 Methionine uptake
时间窗: 12 months
Standardized uptake value (a semiquantitative, unit less measure of radioactivity normalized for injected activity and body weight) will be measured for individual C11 Methionine uptake abnormalities (defined as focally increased uptake higher than background levels in a similar tissue type). All abnormal uptake not in locations common for benign etiologies, such as fracture and degenerative change, will be measured.
次要结局
未报告次要终点
研究者
Yingbing Wang
Radiologist
Massachusetts General Hospital