Musculoskeletal Non-tumoral Pathology Quantitative Perfusion

Study Overview
=================
Brief Summary
-----------------
Study on quantitative perfusion parameters acquired on MR imaging of patients with non-tumoral pathology of the musculoskeletal system.

Detailed Description
-----------------
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.

Official Title
-----------------
Magnetic Resonance (MR) Imaging Quantitative Functional Perfusion Analysis of the Musculoskeletal System: Clinical Application in Non-tumoral Pathology

Conditions
-----------------
Osteonecrosis, Pseudarthrosis, Compartment Syndrome

Intervention / Treatment
-----------------
* Other: T1 mapping and MR perfusion acquisition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal patients<br>Patients with normal bone appearance on conventional MR images | Other: T1 mapping and MR perfusion acquisition<br>* One T1 mapping acquisition with variable flip angles will be performed before contrast injection. One perfusion 3D FSPGR sequence will be acquired after contrast injection<br>|
| Experimental: Carpal osteonecrosis<br>Patients presenting signal anomalies compatible with osteonecrosis of the carpal bones on conventional MR images (hypointensity on T1 weighted sequences, no contrast enhancement). | Other: T1 mapping and MR perfusion acquisition<br>* One T1 mapping acquisition with variable flip angles will be performed before contrast injection. One perfusion 3D FSPGR sequence will be acquired after contrast injection<br>|
| Experimental: Femoral head osteonecrosis<br>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). | Other: T1 mapping and MR perfusion acquisition<br>* One T1 mapping acquisition with variable flip angles will be performed before contrast injection. One perfusion 3D FSPGR sequence will be acquired after contrast injection<br>|
| Experimental: Pseudarthrosis<br>Patients presenting a non consolidated macroscopic bone fracture for over 6 months (clinical history and imaging findings). | Other: T1 mapping and MR perfusion acquisition<br>* One T1 mapping acquisition with variable flip angles will be performed before contrast injection. One perfusion 3D FSPGR sequence will be acquired after contrast injection<br>|
| Experimental: Compartment syndrome<br>Patients with a confirmed compartment syndrome on intra-compartment pressure assessement | Other: T1 mapping and MR perfusion acquisition<br>* One T1 mapping acquisition with variable flip angles will be performed before contrast injection. One perfusion 3D FSPGR sequence will be acquired after contrast injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the plasmatic volume estimation in the 5 study groups (arms) and between the images acquired in the two inclusion sites. | 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 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The plasma-extracellular space transfer constant (Ktrans) in min -1 is a quantitative perfusion parameter that is related to the capillar permeability and blood flow. This parameter can be useful for tissue characterization. | 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. | The extracellular-space-plasma transfer constant or backflow constant (Kep) in min -1 is a quantitative perfusion parameter that is related to the capillar permeability. This parameter can be useful for tissue characterization. | 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. | The extracellular-space extra-vascular space volume (Ve%) in ml is a quantitative perfusion parameter that is related to the tissue cellularity. This parameter can be useful for tissue characterization. | First 6 months of inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic resonance imaging, perfusion, quantitative