Clinical Evaluation of PET-MRI Versus PET-CT in Pediatric Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Diagnostic Accuracy of PET/MRI
研究概览
简要总结
This pilot clinical trial studies how well positron emission tomography (PET)/magnetic resonance imaging (MRI) works compared to PET/computed tomography (CT) in diagnosing younger patients with cancer. PET/MRI and PET/CT are procedures that combine the pictures from a PET scan and an MRI scan or a CT scan. The PET and MRI scans or PET and CT scans are done at the same time with the same machine. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. It is not yet known whether PET/MRI works better than PET/CT in diagnosing younger patients with cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the diagnostic accuracy of PET/MRI as compared to the standard of reference PET/CT in lesion detection and lesion characterization.
SECONDARY OBJECTIVES:
I. Obtain quantitative measurements in various body regions of standardized uptake values (SUV) in normal tissue and foci of pathologic tracer uptake in PET/MRI of pediatric patients with oncologic disease using various magnetic resonance attenuation correction (MRAC) methods and compare those to respective SUV based on CT attenuation correction.
II. Assess the potential for radiation dose reduction with PET/MRI when eliminating CT radiation dose.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are referred by their physician for clinically indicated diagnostic fludeoxyglucose F 18 (18F-FDG) PET/CT (with or without clinically indicated diagnostic MRI)
- •Subjects with malignancies including hematologic disorders
- •Subjects NOT requiring sedation or anesthesia
- •Stable physical medical conditions (patients conscious and comfortable, scheduled for an elective diagnostic imaging)
排除标准
- •Subjects who are unable or unwilling to give their assent to both examinations if > 7 years old
- •Subjects requiring general anesthesia or sedation in order to undergo PET/CT or MRI
- •Subjects unable to undergo magnetic resonance (MR) scanning due to exclusion by University Hospitals-Case Medical Center restriction policies for Magnetic Resonance Imaging (UHCMC MRI restriction policies) as mentioned in the standard UHCMC MRI informed consent form
- •Previously known allergies against MRI contrast agents (exclusion criterion only for contrast enhanced MRI)
- •Pregnant or breast feeding subjects, as determined by standard questionnaire administered prior to scanning
结局指标
主要结局
Diagnostic Accuracy of PET/MRI
时间窗: 1 day
Evaluation of the PET/MR imaging platform will be based on the ability to detect lesions. Evaluation of each lesion will be recorded using the following 5 point rating scale: 1=benign, 2=probably benign, 3=indeterminate, 4=probably malignant, 5=malignant. A Wilcoxon (Mann-Whitney) rank-sum test and two-sided z-test will be used to compare diagnostic accuracy of PET/MRI with PET/CT.
Diagnostic Accuracy of PET/CT
时间窗: 1 day
Evaluation of the PET/CT imaging platform will be based on the ability to detect lesions. Evaluation of each lesion will be recorded using the following 5 point rating scale: 1=benign, 2=probably benign, 3=indeterminate, 4=probably malignant, 5=malignant. A Wilcoxon (Mann-Whitney) rank-sum test and two-sided z-test will be used to compare diagnostic accuracy of PET/CT with PET/MRI.
次要结局
- Radiation Dose Reduction Associated With PET/MRI(1 day)
- Time Effort Associated With the PET/MRI(1 day)
- SUVs Using PET/CT(1 day)
- SUVs Using PET/MRI(1 day)