Radiation-free Bone Imaging by Ultrashort Echo Time (UTE) Magnetic Resonance Tomography (MRT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Comparison of the accuracy of bone anatomy size dimensions measurements between regular MRI and UTE MRI
研究概览
简要总结
In summary, the investigators want to investigate whether UTE sequences are capable to replace imaging techniques involving ionizing radiation for bone imaging in the future. This would improve patient care greatly and might reduce medical imaging associated cancer risk drastically from an epidemiological standpoint. This field of research can be considered cutting-edge. The investigators determine this study promising to provide substantial generalizable knowledge and hope that this study results will improve patient care worldwide considerably.
详细描述
To date, definite depiction of anatomy or pathologies of bony structures requires ionizing radiation by using radiographs or computed tomography (CT) since conventional magnetic resonance imaging (MRI) that does not require ionizing radiation cannot depict bony structures well. Modern MR techniques, collectively referred to as ultrashort time to echo (UTE) sequences, have overcome this issue by acquiring the signal data much faster and therefore are able to acquire sufficient MR signal from bony structures. The investigators want to investigate if UTE sequences are capable to depict bony anatomy and pathology similar to imaging examination techniques involving ionizing radiation. Healthy adult and minor participants, as well as adult and minor participants, referred for a clinically indicated MRI involving the skeletal system will be included.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comparison of the accuracy of bone anatomy size dimensions measurements between regular MRI and UTE MRI
时间窗: There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Outcome measure 1 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be: - size dimensions of the bony structures in three dimensions in millimeter
Comparison of the accuracy of cortical bone depiction between regular MRI and UTE MRI
时间窗: There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Outcome measure 2 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be - clearly visibility of the cortical bone according to a scale 1-4 (1 = cortical bone not good visible; 4 = cortical bone good visible)
Comparison of the accuracy of cancellous bone depiction between regular MRI and UTE MRI
时间窗: There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Outcome measure 3 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be - clearly visibility of the cancellous bone according to a scale 1-4 (1 = cancellous bone not good visible; 4 = cancellous bone good visible)
Comparison of the accuracy of calcification depiction between regular MRI and UTE MRI
时间窗: There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Outcome measure 4 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be - clearly visibility of calcifications according to a scale 1-4 (1 = calcification not good visible; 4 = calcification good visible)
Comparison of the diagnostic performance for depiction of bony anatomy between regular MRI and UTE MRI
时间窗: There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Outcome measure 5 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be: - diagnostic performance measurements for the depiction of bony anatomy (sensitivity, specificity, accuracy)
Comparison of the diagnostic confidence for depiction of bony anatomy between regular MRI and UTE MRI
时间窗: There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Outcome measure 5 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be: - diagnostic confidence measurements for the depiction of bony anatomy (1-4, 1=anatomical bony structure certainly absent, 4= certainly present)
Comparison of the Signal-to-noise (SNR) measurements between regular MRI and UTE MRI
时间窗: There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Outcome measure 6 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be: - Signal-to-noise (SNR)
Comparison of the Contrast-to-noise (CNR) measurements between regular MRI and UTE MRI
时间窗: There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Outcome measure 7 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be: - Contrast-to-noise (CNR)
次要结局
未报告次要终点
研究者
Roman Guggenberger
PD Dr. med. Roman Guggenberger, Sponsor-Investigator, Senior Physician, Institute of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Switzerland
University of Zurich