Musculoskeletal Non-tumoral Pathology Quantitative Perfusion (AFRONT)

August 22, 2018 updated by: Central Hospital, Nancy, France

Magnetic Resonance (MR) Imaging Quantitative Functional Perfusion Analysis of the Musculoskeletal System: Clinical Application in Non-tumoral Pathology

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pedro TEIXEIRA, MD, PhD
  • Phone Number: 33 (3) 83 85 21 61
  • Email: ped_gt@hotmail.com

Study Contact Backup

Study Locations

  • France
    • Lorraine
      • Nancy, Lorraine, France, 54000
        • Recruiting
        • Service d'Imagerie Guilloz, CHRU-Nancy
        • Contact:
        • Contact:
    • Nord-pas-de-Calais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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 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.
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.
First 6 months of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2016

Primary Completion (Anticipated)

February 12, 2019

Study Completion (Anticipated)

February 12, 2020

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCB: 2015-A01604-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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