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Musculoskeletal Non-tumoral Pathology Quantitative Perfusion

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02683252
Acronym
AFRONT
Enrollment
400
Registered
2016-02-17
Start date
2016-02-12
Completion date
2020-02-12
Last updated
2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compartment Syndrome, Osteonecrosis, Pseudarthrosis

Keywords

Magnetic resonance imaging, perfusion, quantitative

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.

Interventions

OTHERT1 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

Sponsors

University Hospital, Lille
CollaboratorOTHER
Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Variation of the plasmatic volume estimation in the 5 study groups (arms) and between the images acquired in the two inclusion sites.3 yearsThe 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

MeasureTime frameDescription
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 yearsThe 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.3 yearsThe 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.First 6 months of inclusionThe 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.

Countries

France

Contacts

Primary ContactPedro TEIXEIRA, MD, PhD
ped_gt@hotmail.com33 (3) 83 85 21 61
Backup ContactGabriela Hossu, PhD
g.hossu@chru-nancy.fr33 (3) 83 15 50 96

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026