The Diagnostic Value of FDG-PET-CT, NaF-PET-CT and Whole-body MRI Compared to Whole-body Xray in the Detection of Bone Lesions in Multiple Myeloma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Bone metastases detection rate - a patient-based analysis
研究概览
简要总结
The purpose of this study is to compare the current standard whole-body x-ray with the advanced imaging techniques FDG-PET-CT, NaF-PET-CT and whole-body MRI in the detection of myeloma bone lesions.
详细描述
Accurate detection of bone lesions in myeloma patients is essential for treatment planning and patient survival.
Newly diagnosed multiple myeloma patients can be enrolled in this study. All participants will at time of diagnosis undergo three project scans (FDG-PET-CT, NaF-PET-CT, whole-body MRI) as well as whole-body x-ray as part of clinical routine practice.
Experienced specialists in the field of radiology and nuclear medicine interpret the images. Each reader performs the evaluations blinded to other imaging results as well as to the patient's clinical information. The reader assesses whether myeloma indicative bone lesions are present in eight predefined skeletal body regions.
Endpoint is purely diagnostic.
Statistics:
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
- •Newly diagnosed multiple myeloma (biopsy proven)
排除标准
- •Prior malignancy
- •Are not able to undergo a MRI scan due to MRI contraindications (e.g. pacemaker)
- •Has any condition that places the subject at an unacceptable risk if he/she undergoes a diagnostic CT scan with iv. contrast (e.g. history of severe allergic reaction to the contrast agent)
- •Severe claustrophobia
结局指标
主要结局
Bone metastases detection rate - a patient-based analysis
时间窗: The three project scans will be performed once and as baseline scans within a maximum of 30 days from the performance of the whole-body x-ray. Image analyses and statistical tests will be done when all project scans have been performed
To compare the proportion of patients with bone disease detected by the four scanning techniques
Bone metastases detection rate - a region-based analysis
时间窗: The three project scans will be performed once and as baseline scans within a maximum of 30 days from the performance of the whole-body x-ray. Image analyses and statistical tests will be done when all project scans have been performed
To compare the number of affected regions with bone disease detected by the four scanning techniques
次要结局
未报告次要终点
研究者
Eva Dyrberg Mortensen
Medical doctor, PhD-student
Herlev Hospital