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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

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date August 23, 2018
Actual Study Start Date  ICMJE February 12, 2016
Estimated Primary Completion Date February 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
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 capilar density of the tissues evaluated and can be useful in tissue characterization
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
  • Variation of the plasma-extra-cellular space transfer contant 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 capilar permeability and blood flow. This parameter can be useful for tissue characterization.
  • Variation of the extra-cellular space-plasma transfer contant (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 capilar 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. [ 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Musculoskeletal Non-tumoral Pathology Quantitative Perfusion
Official Title  ICMJE Magnetic Resonance (MR) Imaging Quantitative Functional Perfusion Analysis of the Musculoskeletal System: Clinical Application in Non-tumoral Pathology
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Osteonecrosis
  • Pseudarthrosis
  • Compartment Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Normal patients
    Patients with normal bone appearance on conventional MR images
    Intervention: Other: T1 mapping and MR perfusion acquisition
  • 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).
    Intervention: Other: T1 mapping and MR perfusion acquisition
  • 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).
    Intervention: Other: T1 mapping and MR perfusion acquisition
  • Experimental: Pseudarthrosis
    Patients presenting a non consolidated macroscopic bone fracture for over 6 months (clinical history and imaging findings).
    Intervention: Other: T1 mapping and MR perfusion acquisition
  • Experimental: Compartment syndrome
    Patients with a confirmed compartment syndrome on intra-compartment pressure assessement
    Intervention: Other: T1 mapping and MR perfusion acquisition
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 11, 2016)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 12, 2020
Estimated Primary Completion Date February 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02683252
Other Study ID Numbers  ICMJE RCB: 2015-A01604-45
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Central Hospital, Nancy, France
Study Sponsor  ICMJE Central Hospital, Nancy, France
Collaborators  ICMJE University Hospital, Lille
Investigators  ICMJE Not Provided
PRS Account Central Hospital, Nancy, France
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP