Musculoskeletal Non-tumoral Pathology Quantitative Perfusion

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02683252
• Date of registration: 28/01/2016
• Prospective Registration: Yes
• Primary sponsor: Central Hospital, Nancy, France
• Public title: Musculoskeletal Non-tumoral Pathology Quantitative Perfusion AFRONT
• Scientific title: Magnetic Resonance (MR) Imaging Quantitative Functional Perfusion Analysis of the Musculoskeletal System: Clinical Application in Non-tumoral Pathology
• Date of first enrolment: February 12, 2016
• Target sample size: 400
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02683252
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Pedro TEIXEIRA, MD, PhD

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Compartment Syndrome

Osteonecrosis

Pseudarthrosis

Intervention(s)

Other: T1 mapping and MR perfusion acquisition

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

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]

Secondary ID(s)

RCB: 2015-A01604-45

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital, Lille