Musculoskeletal Non-tumoral Pathology Quantitative Perfusion (AFRONT)

C

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)

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

Trial contacts and locations

2

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Central trial contact

Gabriela Hossu, PhD; Pedro TEIXEIRA, MD, PhD

Data sourced from clinicaltrials.gov

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