Clinical trial NCT02683252: Musculoskeletal Non-tumoral Pathology Quantitative Perfusion
Official title: Magnetic Resonance (MR) Imaging Quantitative Functional Perfusion Analysis of the Musculoskeletal System: Clinical Application in Non-tumoral Pathology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteonecrosis
Pseudarthrosis
Compartment Syndrome
Keywords: Magnetic resonance imaging
perfusion
quantitative
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
First posted: 2016-02-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Variation of the plasmatic volume estimation in the 5 study groups (arms) and between the images acquired in the two inclusion sites.
timeFrame: 3 years
Secondary outcomes:
measure: 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.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: 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.
timeFrame: First 6 months of inclusion
Other outcomes:
Locations:
city: Nancy
country: France
facility: Service d'Imagerie Guilloz, CHRU-Nancy
state: Lorraine
city: Lille
country: France
facility: CCIAL, CHRU-Lille
state: Nord-pas-de-Calais
Study officials:
References:
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.
citation: Muller GM, Mansson S, Muller MF, Ekberg O, Bjorkman 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.
citation: 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.
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. doi: 10.1007/s00330-004-2305-5. Epub 2004 Apr 6.
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 Sep;23(9):2602-11. doi: 10.1007/s00330-013-2867-1. Epub 2013 May 22.