Musculoskeletal Non-tumoral Pathology Quantitative Perfusion

Osteonecrosis Clinical Trial

— AFRONT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02683252
• Other study ID #: RCB: 2015-A01604-45
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2016
• Est. completion date: February 12, 2020

Study information

• Verified date: July 2018
• Source: Central Hospital, Nancy, France
• Contact: Pedro TEIXEIRA, MD, PhD
• Phone: 33 (3) 83 85 21 61
• Email: ped_gt[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 12, 2020
• Est. primary completion date: February 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Compartment Syndrome
• Compartment Syndromes
• Osteonecrosis
• Pseudarthrosis

Intervention

Other:
• T1 mapping and MR perfusion acquisition
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

Locations

Country	Name	City	State
France	CCIAL, CHRU-Lille	Lille	Nord-pas-de-Calais
France	Service d'Imagerie Guilloz, CHRU-Nancy	Nancy	Lorraine

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	University Hospital, Lille

Country where clinical trial is conducted

France, 

References & Publications (5)

Bervian MR, Ribak S, Livani B. Scaphoid fracture nonunion: correlation of radiographic imaging, proximal fragment histologic viability evaluation, and estimation of viability at surgery: diagnosis of scaphoid pseudarthrosis. Int Orthop. 2015 Jan;39(1):67-72. doi: 10.1007/s00264-014-2579-4. Epub 2014 Nov 16. — View Citation

Mueller D, Schaeffeler C, Baum T, Walter F, Rechl H, Rummeny EJ, Woertler K. Magnetic resonance perfusion and diffusion imaging characteristics of transient bone marrow edema, avascular necrosis and subchondral insufficiency fractures of the proximal femur. Eur J Radiol. 2014 Oct;83(10):1862-9. doi: 10.1016/j.ejrad.2014.07.017. Epub 2014 Jul 30. — View Citation

Müller GM, Månsson S, Müller MF, Ekberg O, Björkman A. Assessment of perfusion in normal carpal bones with dynamic gadolinium-enhanced MRI at 3 Tesla. J Magn Reson Imaging. 2013 Jul;38(1):168-72. doi: 10.1002/jmri.23951. Epub 2012 Nov 27. — View Citation

Rominger MB, Lukosch CJ, Bachmann GF. MR imaging of compartment syndrome of the lower leg: a case control study. Eur Radiol. 2004 Aug;14(8):1432-9. Epub 2004 Apr 6. — View Citation

Teixeira PA, Chanson A, Beaumont M, Lecocq S, Louis M, Marie B, Sirveaux F, Blum A. Dynamic MR imaging of osteoid osteomas: correlation of semiquantitative and quantitative perfusion parameters with patient symptoms and treatment outcome. Eur Radiol. 2013 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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