7.0 Tesla Resonance Magnetic Imaging of the Hand in Systemic Sclerosis

NCT04223817 | Completed

• 1 other identifier: 2019-A02760-57
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Sclerosis (SSc); Magnetic Resonance Imaging (MRI)

Keywords

hand vascular involvement; hand osteoarticular involvement; magnetic resonnance imaging 7.0 tesla

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI

  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

  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

  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

  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

  7 days maximum (delay between realization of the RMI and its final interpretation)

Study Arms (1)

7.0 Tesla MRI of both hands

EXPERIMENTAL

Single 7.0 Tesla MRI of both hands for all the SSc and control subjects

Device: 7.0 T RMI

Interventions

7.0 T RMI DEVICE

Single 7.0 Tesla MRI of both hands in the same time

7.0 Tesla MRI of both hands

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• For both:
• Age ≥ 18 years-old
• Written informatory consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Poitiers University Hospital

Poitiers, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SSc patients compared to control subjects without SSc matched on sex and age

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 10, 2020
• Study Start: April 12, 2021
• Primary Completion: September 2, 2025
• Study Completion: September 2, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

FR (1)