Musculoskeletal Non-tumoral Pathology Quantitative Perfusion

Not Applicable

• Conditions: Compartment Syndrome; Osteonecrosis; Pseudarthrosis

• Registration Number: NCT02683252
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-02-11
• Study Start: 2016-02-12
• Study First Posted: 2016-02-17
• Status Verified: 2018-07
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23
• Primary Completion: 2019-02-12
• Study Completion: 2020-02-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Variation of the plasmatic volume estimation in the 5 study groups (arms) and between the images acquired in the two inclusion sites.	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

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
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	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.

Trial Locations

Locations (2)

Service d'Imagerie Guilloz, CHRU-Nancy; 🇫🇷 Nancy, Lorraine, France

CCIAL, CHRU-Lille; 🇫🇷 Lille, Nord-pas-de-Calais, France