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Musculoskeletal Non-tumoral Pathology Quantitative Perfusion (AFRONT)

Primary Purpose

Osteonecrosis, Pseudarthrosis, Compartment Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
T1 mapping and MR perfusion acquisition
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteonecrosis focused on measuring Magnetic resonance imaging, perfusion, quantitative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'Imagerie Guilloz, CHRU-NancyRecruiting
  • CCIAL, CHRU-LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Normal patients

Carpal osteonecrosis

Femoral head osteonecrosis

Pseudarthrosis

Compartment syndrome

Arm Description

Patients with normal bone appearance on conventional MR images

Patients presenting signal anomalies compatible with osteonecrosis of the carpal bones on conventional MR images (hypointensity on T1 weighted sequences, no contrast enhancement).

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).

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 28, 2016
Last Updated
August 22, 2018
Sponsor
Central Hospital, Nancy, France
Collaborators
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT02683252
Brief Title
Musculoskeletal Non-tumoral Pathology Quantitative Perfusion
Acronym
AFRONT
Official Title
Magnetic Resonance (MR) Imaging Quantitative Functional Perfusion Analysis of the Musculoskeletal System: Clinical Application in Non-tumoral Pathology
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 12, 2016 (Actual)
Primary Completion Date
February 12, 2019 (Anticipated)
Study Completion Date
February 12, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
University Hospital, Lille

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteonecrosis, Pseudarthrosis, Compartment Syndrome
Keywords
Magnetic resonance imaging, perfusion, quantitative

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal patients
Arm Type
Experimental
Arm Description
Patients with normal bone appearance on conventional MR images
Arm Title
Carpal osteonecrosis
Arm Type
Experimental
Arm Description
Patients presenting signal anomalies compatible with osteonecrosis of the carpal bones on conventional MR images (hypointensity on T1 weighted sequences, no contrast enhancement).
Arm Title
Femoral head osteonecrosis
Arm Type
Experimental
Arm Description
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).
Arm Title
Pseudarthrosis
Arm Type
Experimental
Arm Description
Patients presenting a non consolidated macroscopic bone fracture for over 6 months (clinical history and imaging findings).
Arm Title
Compartment syndrome
Arm Type
Experimental
Arm Description
Patients with a confirmed compartment syndrome on intra-compartment pressure assessement
Intervention Type
Other
Intervention Name(s)
T1 mapping and MR perfusion acquisition
Intervention Description
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 Measure Information:
Title
Variation of the plasmatic volume estimation in the 5 study groups (arms) and between the images acquired in the two inclusion sites.
Description
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
Time Frame
3 years
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 years
Title
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.
Description
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.
Time Frame
3 years
Title
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.
Description
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.
Time Frame
First 6 months of inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro TEIXEIRA, MD, PhD
Phone
33 (3) 83 85 21 61
Email
ped_gt@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela Hossu, PhD
Phone
33 (3) 83 15 50 96
Email
g.hossu@chru-nancy.fr
Facility Information:
Facility Name
Service d'Imagerie Guilloz, CHRU-Nancy
City
Nancy
State/Province
Lorraine
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Blum, MD, PhD
Phone
0033 3 83 85 21 61
Email
alain.blum@gmail.com
First Name & Middle Initial & Last Name & Degree
Pedro Teixeira, MD, PhD
Phone
0033 3 83 85 21 61
Email
ped_gt@hotmail.com
Facility Name
CCIAL, CHRU-Lille
City
Lille
State/Province
Nord-pas-de-Calais
ZIP/Postal Code
59036
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Cotten, MD, PhD
Phone
0033 3 20 44 59 62
Email
Vanessa.vandendooren@CHRU-LILLE.FR
First Name & Middle Initial & Last Name & Degree
Guillaume Lefebvre, MD
Phone
0033 3 20 44 59 62
Email
guillaume.lefebvre59@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25129825
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.
Results Reference
background
PubMed Identifier
23188589
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.
Results Reference
background
PubMed Identifier
25398469
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.
Results Reference
background
PubMed Identifier
15067424
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.
Results Reference
background
PubMed Identifier
23695220
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.
Results Reference
result

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Musculoskeletal Non-tumoral Pathology Quantitative Perfusion

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