Systemic Sclerosis (SSc)PREM'SNCT04223817
7.0 Tesla Resonance Magnetic Imaging of the Hand in Systemic Sclerosis
A study testing 7.0 T RMI in people with Systemic Sclerosis (SSc) and Magnetic Resonance Imaging (MRI), run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc), Magnetic Resonance Imaging (MRI)
- What is being tested?
- 7.0 T RMI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2021to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Individuals with reinforced protection: minors, judiciary or administrative decision
- No affiliation to social insurance
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- 7.0 T RMI
- Keywords
- hand vascular involvement, hand osteoarticular involvement, magnetic resonnance imaging 7.0 tesla
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7.0 T RMIDevice
Single 7.0 Tesla MRI of both hands in the same time
| Study group | Role | What they receive |
|---|---|---|
| 7.0 Tesla MRI of both hands | Experimental | Single 7.0 Tesla MRI of both hands for all the SSc and control subjects Receives: Device: 7.0 T RMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Digital arteries count in both hand in 7.0 T RMI in SSc patients and control subjects
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 days maximum (delay between realization of the RMI and its final interpretation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start12 Apr 2021
- Primary completion2 Sep 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SSc patients compared to control subjects without SSc matched on sex and age
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223817
- Sponsor's protocol ID
- 2019-A02760-57
- Acronym
- PREM'S
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2019
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of 7.0 Tesla RMI in Screening of Osteoarticular Involvement and Vasculopathy of the Hands in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04223817
- Acronym / sponsor ID
- PREM'S / 2019-A02760-57
- Keywords
- hand vascular involvement, hand osteoarticular involvement, magnetic resonnance imaging 7.0 tesla
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SSc patients compared to control subjects without SSc matched on sex and age
| Arm | Type | Receives |
|---|---|---|
| 7.0 Tesla MRI of both hands | Experimental | Device: 7.0 T RMISingle 7.0 Tesla MRI of both hands for all the SSc and control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with SSc:
- Control subjects:
- For both:
Key exclusion criteria (9 listed)
- Patients with SSc:
- For both:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7.0 T RMISingle 7.0 Tesla MRI of both hands in the same time | Device | 7.0 Tesla MRI of both hands |
Primary outcome
Frequency of hand osteoarticular involvement in SSc and control subjects in 7.0 T RMI
Time frame: 7 days maximum (delay between realization of the RMI and its final interpretation)
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 secondary outcomes
Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 7 days maximum (delay between realization of the RMI and its final interpretation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7.0 T RMI in people with Systemic Sclerosis (SSc) and Magnetic Resonance Imaging (MRI), run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of hand osteoarticular involvement in SSc and control subjects in 7.0 T RMI (time frame: 7 days maximum (delay between realization of the RMI and its final interpretation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.