Musculoskeletal Non-tumoral Pathology Quantitative Perfusion (AFRONT)

Central Hospital, Nancy, France

Status: Unknown

Conditions: Compartment Syndrome; Pseudarthrosis; Osteonecrosis

Treatments: Other: T1 mapping and MR perfusion acquisition

Study type: Interventional

Funder types: Other

Identifiers

NCT02683252

RCB: 2015-A01604-45

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 5 patient groups

Normal patients

Experimental group

Description:

Patients with normal bone appearance on conventional MR images

Treatment:

Other: T1 mapping and MR perfusion acquisition

Carpal osteonecrosis

Experimental group

Description:

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

Treatment:

Other: T1 mapping and MR perfusion acquisition

Femoral head osteonecrosis

Experimental group

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).

Treatment:

Other: T1 mapping and MR perfusion acquisition

Pseudarthrosis

Experimental group

Description:

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

Treatment:

Other: T1 mapping and MR perfusion acquisition

Compartment syndrome

Experimental group

Description:

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

Treatment:

Other: T1 mapping and MR perfusion acquisition