Musculoskeletal Non-tumoral Pathology Quantitative Perfusion

NCT ID: NCT02683252

Last Updated: 2018-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-12

Study Completion Date

2020-02-12

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteonecrosis Pseudarthrosis Compartment Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Normal patients

Patients with normal bone appearance on conventional MR images

Group Type EXPERIMENTAL

T1 mapping and MR perfusion acquisition

Intervention Type OTHER

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

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).

Group Type EXPERIMENTAL

T1 mapping and MR perfusion acquisition

Intervention Type OTHER

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

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).

Group Type EXPERIMENTAL

T1 mapping and MR perfusion acquisition

Intervention Type OTHER

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

Pseudarthrosis

Patients presenting a non consolidated macroscopic bone fracture for over 6 months (clinical history and imaging findings).

Group Type EXPERIMENTAL

T1 mapping and MR perfusion acquisition

Intervention Type OTHER

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

Compartment syndrome

Patients with a confirmed compartment syndrome on intra-compartment pressure assessement

Group Type EXPERIMENTAL

T1 mapping and MR perfusion acquisition

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CCIAL, CHRU-Lille

Lille, Hauts-de-France, France

Site Status RECRUITING

Service d'Imagerie Guilloz, CHRU-Nancy

Nancy, Lorraine, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pedro TEIXEIRA, MD, PhD

Role: CONTACT

33 (3) 83 85 21 61

Gabriela Hossu, PhD

Role: CONTACT

33 (3) 83 15 50 96

Facility Contacts

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Anne Cotten, MD, PhD

Role: primary

0033 3 20 44 59 62

Guillaume Lefebvre, MD

Role: backup

0033 3 20 44 59 62

Alain Blum, MD, PhD

Role: primary

0033 3 83 85 21 61

Pedro Teixeira, MD, PhD

Role: backup

0033 3 83 85 21 61

References

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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.

Reference Type BACKGROUND
PMID: 25129825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23188589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25398469 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15067424 (View on PubMed)

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.

Reference Type RESULT
PMID: 23695220 (View on PubMed)

Other Identifiers

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RCB: 2015-A01604-45

Identifier Type: -

Identifier Source: org_study_id

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