PET-MRI: Evaluation, Optimization and Clinical Implementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Lesion Based Standard Uptake Values (SUV)
研究概览
简要总结
This randomized pilot clinical trial studies how well positron emission tomography (PET)-magnetic resonance imaging (MRI) works compared to standard-of-care PET-computed tomography (CT) in diagnosing patients with cancer, cardiac diseases, or neurologic diseases. PET-MRI combines two imaging methods that can be used to evaluate disease. PET-MRI is similar to standard-of-care PET-CT, but exposes the patient to less radiation. It is not yet known whether PET-MRI produces better image quality than PET-CT in diagnosing patients with cancer, cardiac disease, or neurologic disease.
详细描述
PRIMARY OBJECTIVES:
I. To assess and optimize image quality of PET and MRI focusing on technical artifacts and their correction.
II. To assess the accuracy of PET quantification based on MR attenuation correction (MRAC) derived from various MRI sequences and reconstruction algorithms including the effect of routinely used Gadolinium-based contrast agents on MRAC.
III. To determine the clinical and diagnostic accuracy of PET-MRI in comparison to standard-of-care diagnostic imaging.
IV. To assess the efficacy and workflow in combining PET and MRI in one single examination as compared to separate imaging studies.
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
- •Clinically indicated PET/PET-CT (with or without clinically indicated diagnostic MRI)
- •Presenting with one of the four conditions specified below
- •Fludeoxyglucose F 18 (FDG) avid cancers
- •Cardiac disease (cardiac viability assessment)
- •Neurologic disorders (dementia)
- •Inflammatory disease (for example fever of unknown origin, vasculitis, osteomyelitis)
排除标准
- •Pregnancy and lactation
- •Contraindications to undergo MRI
- •Cardiac pacemaker and metal devices (as specified in a separate MRI Informed consent)
- •Claustrophobia or inability to tolerate MRI examination (lay still for approximately 1 hour and hold breath intermittently)
- •Previously known allergies against MRI contrast agents (exclusion criterion only for contrast enhanced MRI)
- •Renal insufficiency: glomerular filtration rate (GFR) < 40ml/min/1.73m^2 and following European Society of Urogenital Radiology (ESUR) guidelines (exclusion criterion only for contrast enhanced MRI)
- •Individuals who are not willing or capable of giving informed consent or assent (with legal guardian consent)
研究组 & 干预措施
PET-CT and PET-MRI
Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.
干预措施: positron emission tomography (Device)
PET-CT and PET-MRI
Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.
干预措施: computed tomography (Device)
PET-CT and PET-MRI
Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.
干预措施: magnetic resonance imaging (Device)
结局指标
主要结局
Lesion Based Standard Uptake Values (SUV)
时间窗: Day 1
Lesion based SUV will be estimated and compared for PET-MR and PET-CT images in normal organs and compared. A two-sided two-sample t-test will be used to show significance of difference.
Overall Image Quality Scores
时间窗: Day 1
Overall image quality scores obtained from the two imaging modalities will be compared with the hypothesis that hybrid PET-MRI images is as good as PET-CT images or superior (not inferior) to the PET-CT images. Evaluation of overall image quality will be assessed using the following criteria: 1=excellent, 2=good, 3=acceptable, 4=poor, 5=not acceptable. A Wilcoxon (Mann-Whitney) rank-sum test with a 0.100 significance level will be used.
Time Effort Associated With the PET-MRI Versus PET-CT With MRI
时间窗: Day 1
Statistical difference in time between PET-MRI versus sequential approach for PET-CT plus MRI. Workflow with shortest timely efforts and sufficient diagnostic information will be established as routine procedure.
Area Under the Receiver Operating Characteristic Curve
时间窗: Day 1
A two-sided z-test will be used to detect the difference in the area under the curve showing the sensitivity, specificity, positive and negative predictive values as well as accuracy of diagnostic information.
Radiation Dose Reduction With PET-MRI
时间窗: Day 1
Dose measurements will be used to calculate effective radiation dose in each patient. Dose calculations of effective dose will be used to estimate dose savings in omitting the CT component of PET-CT. Statistical tests will use a 0.10 significance level and will be 2-sided
次要结局
未报告次要终点