7.0 Tesla Resonance Magnetic Imaging of the Hand in Systemic Sclerosis (PREM'S)

Contribution of 7.0 Tesla RMI in Screening of Osteoarticular Involvement and Vasculopathy of the Hands in Systemic Sclerosis

Systemic sclerosis (SSc) is a rare systemic autoimmune disease with specific osteoarticular pattern of unknown mechanism. Ischemic phenomenon have been suggested to participate to the osteoarticular involvement in SSc. To date, osteoarticular pattern and hand vascular involvement have been few studied in magnetic resonance imaging in SSc, and most often with low resolution RMI.

7 Tesla RMI allows high resolution for morphology examination, together with dynamic and functional vascular study and sodium articular concentration. Indeed, the aim of the study is to describe hand osteoarticular and vascular involvement in SSc, as well as sodium articular concentration. Clinico-biological association will be also assessed.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Sclerosis; 7.0 Tesla Magnetic Resonance Imaging; Hand Vascular Involvement; Hand Osteoarticular Involvement
• Intervention / Treatment: Device: 7.0 T RMI

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mickaël MARTIN, MD, PhD; Phone Number: +33 0549444004; Email: mickael.martin@chu-poitiers.fr
• Study Contact Backup: Name: Cédric LANDRON, MD, PhD; Phone Number: +33 0549444004; Email: cedric.landron@chu-poitiers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with SSc:

  - ScS fulfilling ACR/EULAR 2013 classification criteria and followed in the department of internal medicine of Poitiers University Hospital, without clinical signs of digital arthrose

• Control subjects:

  - Hospitalized patients in the department of internal medicine of Poitiers University Hospital, without Raynaud's phenomenon, neither antecedent of inflammatory rheumatism and/or autoimmune disease, neither inflammatory articular symptoms during the previous month and no clinical signs of arthoses and/or arthritis at the inclusion in the study

• For both:

  • Age ≥ 18 years-old
  • Written informatory consent

Exclusion Criteria:

• Patients with SSc:

  - SSc associated with other define autoimmune disease (overlap syndrome)

• For both:

  • Absolute contraindication to 7.0 T RMI: pregnancy; ocular metallic foreign body ; cardiac pacemaker ; neurostimulator no compatible 7.0 T RMI ; cochlear implants; all electronic medical device implantedfor less than 6 weeks ; metallic heart valve ; old cranial vascular clips
  • Individuals with current health condition not allowing realization of the 7.0 T RMI in sufficient comfort conditions according to investigator appreciation (i.e. acute cardiac and/or respiratory failure, impossibility to maintain procubitus, bedridden individuals, claustrophobia)
  • Individuals under tutorship or guardianship
  • Individuals with reinforced protection: minors, judiciary or administrative decision
  • No affiliation to social insurance
  • Pregnancy or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 7.0 Tesla MRI of both hands; Single 7.0 Tesla MRI of both hands for all the SSc and control subjects	Device: 7.0 T RMI; Single 7.0 Tesla MRI of both hands in the same time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of hand osteoarticular involvement in SSc and control subjects in 7.0 T RMI	Frequency of type and localisation of hand osteoarticular abnormality (erosions, bone oedema, synovitis, tenosynovitis, intraarticular swoilling) in 7.0 T RMI in patients with SSc and control subjects	7 days maximum (delay between realization of the RMI and its final interpretation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI	Digital arteries count in both hand in 7.0 T RMI in SSc patients and control subjects	7 days maximum (delay between realization of the RMI and its final interpretation)
Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI	Lumen area of the selective section of the vessel (in mm2) in 7.0 T RMI in SSc patients and control subjects	7 days maximum (delay between realization of the RMI and its final interpretation)
Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI	Quality of arterial opacification in terms of percentage of digital artery that did not reach the first phalanx, in 7.0 T RMI in SSc patients and control subjects	7 days maximum (delay between realization of the RMI and its final interpretation)
Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI	Quality of venous return in terms of percentage of no visible venous return as far as the proximal phalanx in 7.0 T RMI in SSc patients and control subjects	7 days maximum (delay between realization of the RMI and its final interpretation)
Correlation between hand osteoarticular involvement in 7.0 T RMI and general and SSc-related factors, including hand vascular involvement, in SSc patients	Proportion of hand osteoarticular abnormalities and : age (yrs) ; SSc duration (yrs) ; bone mass index ; modified Rodnan skin score (0-51) ; interlabial length (cm) ; arterial pattern in the hand in 7.0 T RMI ; proportions of female, active tabagism, SSc subtypes, SSc-related autoantibodies, antiphospholipid autoantibodies, immunosuppressant use, vasoactive drugs and SSc-related visceral involvement (Raynaud's phenomenon, digital tip ulcerations and/or gangrene and/or amputation, arterial pulmonary hypertension, interstitial lung disease, upper and/or lower digital tract involvement, renal crisis, arthritis, inflammatory myopathy, subcutaneous calcifications, telangiectasia) ; EUSTAR-Activity Index ; NT-proBNP level (ng/mL) ; troponin level (ng/mL) ; C reactive protein level (mg/L) ; proportion of capillaroscopic pattern (cutulo's classification) ; Raynaud's Condition Score ; patient's visual scale for Raynaud's phenomenon severity (1 to 10) ; SSc-HAQ ; "main de Cochin" score	7 days maximum (delay between realization of the RMI and its final interpretation)
Correlation between hand arterial involvement in 7.0 T RMI and general and SSc-related factors, including hand osteoarticular involvement, in SSc patients	Proportion of hand hand arterial abnormalities and : age (yrs) ; SSc duration (yrs) ; bone mass index ; modified Rodnan skin score (0-51) ; interlabial length (cm) ; hand osteoarticular abnormalities in 7.0 T RMI ; proportions of female, active tabagism, SSc subtypes, SSc-related autoantibodies, antiphospholipid autoantibodies, immunosuppressant use, vasoactive drugs and SSc-related visceral involvement (Raynaud's phenomenon, digital tip ulcerations and/or gangrene and/or amputation, arterial pulmonary hypertension, interstitial lung disease, upper and/or lower digital tract involvement, renal crisis, arthritis, inflammatory myopathy, subcutaneous calcifications, telangiectasia) ; EUSTAR-Activity Index ; NT-proBNP level (ng/mL) ; troponin level (ng/mL) ; C reactive protein level (mg/L) ; proportion of capillaroscopic pattern (cutulo's classification) ; Raynaud's Condition Score ; patient's visual scale for Raynaud's phenomenon severity (1 to 10) ; SSc-HAQ ; "main de Cochin" score	7 days maximum (delay between realization of the RMI and its final interpretation)
Sodium articular concentration in the hand in 7.0 T RMI in SSc patients and control subjects	Mean values of sodium articular concentration in the hands of SSc patients of control subjects	7 days maximum (delay between realization of the RMI and its final interpretation)

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: 2019-A02760-57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No