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Musculoskeletal Non-tumoral Pathology Quantitative Perfusion (AFRONT)

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ClinicalTrials.gov Identifier: NCT02683252
Recruitment Status : Unknown
Verified July 2018 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : February 17, 2016
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
University Hospital, Lille
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteonecrosis Pseudarthrosis Compartment Syndrome Other: T1 mapping and MR perfusion acquisition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance (MR) Imaging Quantitative Functional Perfusion Analysis of the Musculoskeletal System: Clinical Application in Non-tumoral Pathology
Actual Study Start Date : February 12, 2016
Estimated Primary Completion Date : February 12, 2019
Estimated Study Completion Date : February 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Normal patients
Patients with normal bone appearance on conventional MR images
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

Experimental: 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).
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

Experimental: 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).
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

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

Experimental: Compartment syndrome
Patients with a confirmed compartment syndrome on intra-compartment pressure assessement
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




Primary Outcome Measures :
  1. Variation of the plasmatic volume estimation in the 5 study groups (arms) and between the images acquired in the two inclusion sites. [ Time Frame: 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 :
  1. 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. [ Time Frame: 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.

  2. 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. [ Time Frame: 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.

  3. 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. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683252


Contacts
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Contact: Pedro TEIXEIRA, MD, PhD 33 (3) 83 85 21 61 ped_gt@hotmail.com
Contact: Gabriela Hossu, PhD 33 (3) 83 15 50 96 g.hossu@chru-nancy.fr

Locations
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France
Service d'Imagerie Guilloz, CHRU-Nancy Recruiting
Nancy, Lorraine, France, 54000
Contact: Alain Blum, MD, PhD    0033 3 83 85 21 61    alain.blum@gmail.com   
Contact: Pedro Teixeira, MD, PhD    0033 3 83 85 21 61    ped_gt@hotmail.com   
CCIAL, CHRU-Lille Recruiting
Lille, Nord-pas-de-Calais, France, 59036
Contact: Anne Cotten, MD, PhD    0033 3 20 44 59 62    Vanessa.vandendooren@CHRU-LILLE.FR   
Contact: Guillaume Lefebvre, MD    0033 3 20 44 59 62    guillaume.lefebvre59@gmail.com   
Sponsors and Collaborators
Central Hospital, Nancy, France
University Hospital, Lille
Publications of Results:
Other Publications:
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02683252    
Other Study ID Numbers: RCB: 2015-A01604-45
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: July 2018
Keywords provided by Central Hospital, Nancy, France:
Magnetic resonance imaging
perfusion
quantitative
Additional relevant MeSH terms:
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Osteonecrosis
Compartment Syndromes
Pseudarthrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Muscular Diseases
Vascular Diseases
Cardiovascular Diseases
Fractures, Ununited
Fractures, Bone
Wounds and Injuries