Magnetic Resonance (MR) Imaging Quantitative Functional Perfusion Analysis of the Musculoskeletal System: Clinical Application in Non-tumoral Pathology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Variation of the plasmatic volume estimation in the 5 study groups (arms) and between the images acquired in the two inclusion sites.
研究概览
简要总结
Study on quantitative perfusion parameters acquired on MR imaging of patients with non-tumoral pathology of the musculoskeletal system.
详细描述
Patients referred for the MR imaging evaluation of non-tumoral musculoskeletal pathology (osteonecrosis, pseudarthrosis and compartment syndrome) will have their MR protocols complemented by a contrast enhanced perfusion study. In this patients standard clinical evaluation is already performed with contrast medium injection (Gadolinium) and no additional injection is required.
After post processing multiple quantitative perfusions parameters will be extracted (e.g. plasmatic volume, transfer constant, backflow constant, extra-cellular extra vascular space volume). The variation of these parameters in patients with and without the previously described conditions will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •affiliation to a social security regimen
- •Signature of an informed consent
- •Clinical suspicion of one of the studied conditions (osteonecrosis of the wrist, osteonecrosis of the femoral head, pseudarthrosis and compartment syndrome)
排除标准
- •MR contraindications
- •Contraindications to contrast injection
- •Previous history of allergy to gadolinium containing contrast medium
- •Presence of metallic hardware in the study zone
- •Pregnancy
- •Patients under tutelage
研究组 & 干预措施
Normal patients
Patients with normal bone appearance on conventional MR images
干预措施: T1 mapping and MR perfusion acquisition (Other)
Carpal osteonecrosis
Patients presenting signal anomalies compatible with osteonecrosis of the carpal bones on conventional MR images (hypointensity on T1 weighted sequences, no contrast enhancement).
干预措施: T1 mapping and MR perfusion acquisition (Other)
Femoral head osteonecrosis
Patients presenting signal anomalies compatible with osteonecrosis of the femoral head on conventional MR images (fat containing signal anomalies with geographic contours in the femoral epiphysis).
干预措施: T1 mapping and MR perfusion acquisition (Other)
Pseudarthrosis
Patients presenting a non consolidated macroscopic bone fracture for over 6 months (clinical history and imaging findings).
干预措施: T1 mapping and MR perfusion acquisition (Other)
Compartment syndrome
Patients with a confirmed compartment syndrome on intra-compartment pressure assessement
干预措施: T1 mapping and MR perfusion acquisition (Other)
结局指标
主要结局
Variation of the plasmatic volume estimation in the 5 study groups (arms) and between the images acquired in the two inclusion sites.
时间窗: 3 years
The plasmatic volume (Vp%) in ml is a quantitative perfusion parameter that describes the capillar density of the tissues evaluated and can be useful in tissue characterization
次要结局
- Variation of the plasma-extra-cellular space transfer constant in the 5 study groups (arms) and between the images acquired in the two inclusion sites.(3 years)
- Variation of the extra-cellular space-plasma transfer constant (backflow constant) in the 5 study groups (arms) and between the images acquired in the two inclusion sites.(3 years)
- Variation of the extra-cellular extra-vascular space volume in the 5 study groups (arms) and between the images acquired in the two inclusion sites.(First 6 months of inclusion)