NCT02683252

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

February 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
Last Updated

August 23, 2018

Status Verified

July 1, 2018

Enrollment Period

3 years

First QC Date

January 28, 2016

Last Update Submit

August 22, 2018

Conditions

OsteonecrosisPseudarthrosisCompartment Syndrome

Keywords

Magnetic resonance imagingperfusionquantitative

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (5)

Normal patients

EXPERIMENTAL

Patients with normal bone appearance on conventional MR images

Other: T1 mapping and MR perfusion acquisition

Carpal osteonecrosis

EXPERIMENTAL

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

Femoral head osteonecrosis

EXPERIMENTAL

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

Pseudarthrosis

EXPERIMENTAL

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

Other: T1 mapping and MR perfusion acquisition

Compartment syndrome

EXPERIMENTAL

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

Other: T1 mapping and MR perfusion acquisition

Interventions

T1 mapping and MR perfusion acquisitionOTHER

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 osteonecrosisCompartment syndromeFemoral head osteonecrosisNormal patientsPseudarthrosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CCIAL, CHRU-Lille

Lille, Hauts-de-France, 59036, France

RECRUITING

Service d'Imagerie Guilloz, CHRU-Nancy

Nancy, Lorraine, 54000, France

RECRUITING

Related Publications (5)

  • 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.

    PMID: 25129825BACKGROUND

  • 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.

    PMID: 23188589BACKGROUND

  • 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.

    PMID: 25398469BACKGROUND

  • 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.

    PMID: 15067424BACKGROUND

  • 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.

    PMID: 23695220RESULT

MeSH Terms

Conditions

OsteonecrosisPseudarthrosisCompartment Syndromes

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsFractures, UnunitedFractures, BoneWounds and InjuriesMuscular DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Pedro TEIXEIRA, MD, PhD

CONTACT

33 (3) 83 85 21 61ped_gt@hotmail.com

Gabriela Hossu, PhD

CONTACT

33 (3) 83 15 50 96g.hossu@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 17, 2016

Study Start

February 12, 2016

Primary Completion

February 12, 2019

Study Completion

February 12, 2020

Last Updated

August 23, 2018

Record last verified: 2018-07

Locations

FR(2)