Single-center Prospective Comparison of Diagnostic Performance of Deep-learning Agumented UTE/ZTE MRI Sequences and Standard-of-care Low Dose CT for Rheumatologic Patients With Musculoskeletal Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visibility of trabecular bone
研究概览
简要总结
The goal of this clinical trial is to determine how effectively bone structures of the human skeleton can be visualized using Deep Learning (DL) augmented Magnetic Resonance Imaging (MRI) in individuals with inflammatory and degenerative joint changes, compared to Computed Tomography (CT). MRI is a technique that operates without the use of X-rays. The main question it aims to answer is:
- Can DL MRI accurately depict bone structures as well as CT?
- Can DL MRI be used as an alternative to CT to avoid exposure to X-rays in the future?
Researchers will compare DL MRI scans to CT scans to see if DL MRI can effectively replace CT in visualizing bone structures without the use of radiation.
Participants will:
- Undergo MRI scans of their skeletal system that will then be processed using DL.
- Undergo CT scans of the same body region for comparison purposes.
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
- Single (Outcomes Assessor)
盲法说明
The radiologists who perform the readout will be blinded to the reference low dose CT scan to avoid being primed for certain bony anatomy and pathology by evaluating the low dose CT first. The reference low dose CT scan will be read in a separate session.
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
- •Referral for a clinically indicated MRI examination of the musculoskeletal system to assess inflammatory and degenerative joint changes.
- •Willingness to sign the informed consent form.
- •No contraindications for a CT examination (e.g., claustrophobia).
排除标准
- •No signed informed consent form.
- •Patients under 18 years of age.
- •Pregnant women.
- •The calculated effective dose of the CT examination exceeds 5 mSv.
结局指标
主要结局
Visibility of trabecular bone
时间窗: one day (day of MRI and CT examination)
Scale from 1 to 4 1. hardly visible 2. diagnostic with some artifact 3. diagnostic with little artifact 4. very good depiction A higher score means better image quality.
Visibility of cortical bone
时间窗: one day (day of MRI and CT examination)
Scale from 1 to 4 1. hardly visible 2. diagnostic with some artifact 3. diagnostic with little artifact 4. very good depiction A higher score means better image quality.
Visibility of soft tissue calcifications
时间窗: one day (day of MRI and CT examination)
Scale from 1 to 4 1. hardly visible 2. diagnostic with some artifact 3. diagnostic with little artifact 4. very good depiction A higher score means better image quality.
Contrast to noise ratio
时间窗: one day (day of MRI and CT examination)
Average signal of erosion minus average signal of adjacent healthy bone, divided by the average background signal A higher score means better contrast of erosions when standardized for healthy adjacent bone and against the background.
Total score for bone erosions
时间窗: one day (day of MRI and CT examination)
Each bone is scored separately. The scale is 0-10, based on the proportion of eroded bone compared to the "assessed bone volume," judged on all available images: 0: no erosion; 1: 1-10% of bone eroded; 2: 11-20%, etc. For long bones, the "assessed bone volume" is from the articular surface (or its best estimated position if absent) to a depth of 1 cm, while in carpal/tarsal bones it is the whole bone. Example of bone list for hands: carpal bones, distal radius, distal ulna, metacarpal bases; metacarpophalangeal, MCP, joints: metacarpal head, phalangeal base; maximum points: 230. A higher score means more bone erosions. Note: The total score will vary according to body area imaged, this will be taken into account in the final analysis.
Total score for joint space narrowing
时间窗: one day (day of MRI and CT examination)
0: no narrowing, 1: focal or mild (\< 33%), 2: moderate (34-66%), 3: moderate to severe (67-99%), 4: ankylosis A higher score means more joint space narrowing. Note: The total score will vary according to body area imaged, this will be taken into account in the final analysis.
Signal to noise ratio
时间窗: one day (day of MRI and CT examination)
Average signal of erosion divided by the average background signal A higher score means better contrast of erosions against the background.
次要结局
未报告次要终点
研究者
Roman Guggenberger
Senior Physician (Leitender Arzt)
University of Zurich