Magnetic Resonance (MR) Imaging Quantitative Functional Perfusion Analysis of the Musculoskeletal System: Clinical Application in Non-tumoral Pathology
| Registry | NCT02683252, acronym AFRONT |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, diagnostic |
| Enrollment | 400 (Estimated) |
| Sponsor | Central Hospital, Nancy, France (Other); collaborators: University Hospital, Lille |
| Conditions | Osteonecrosis, Pseudarthrosis, Compartment Syndrome |
| Interventions | T1 mapping and MR perfusion acquisition (Other) |
| Dates | start 2016-02-12, primary completion 2019-02-12 (estimated), completion 2020-02-12 (estimated), first posted 2016-02-17, last updated 2018-08-23 |
| Locations | 2 sites in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Osteonecrosis All trials for Pseudarthrosis All trials of T1 mapping and MR perfusion acquisition
Study on quantitative perfusion parameters acquired on MR imaging of patients with non-tumoral pathology of the musculoskeletal system.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Normal patients | Experimental | Other: T1 mapping and MR perfusion acquisition | Patients with normal bone appearance on conventional MR images |
| Carpal osteonecrosis | Experimental | Other: T1 mapping and MR perfusion acquisition | Patients presenting signal anomalies compatible with osteonecrosis of the carpal bones on conventional MR images (hypointensity on T1 weighted sequences, no contrast enhancement). |
| Femoral head osteonecrosis | Experimental | Other: T1 mapping and MR perfusion acquisition | 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). |
| Pseudarthrosis | Experimental | Other: T1 mapping and MR perfusion acquisition | Patients presenting a non consolidated macroscopic bone fracture for over 6 months (clinical history and imaging findings). |
| Compartment syndrome | Experimental | Other: T1 mapping and MR perfusion acquisition | Patients with a confirmed compartment syndrome on intra-compartment pressure assessement |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| CCIAL, CHRU-Lille | Lille, Hauts-de-France | France | Recruiting |
| Service d'Imagerie Guilloz, CHRU-Nancy | Nancy, Lorraine | France | Recruiting |