Systemic Sclerosis (SSc)NCT07228429
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
An observational study of Systemic Sclerosis (SSc) and Calcinosis Cutis, run by Yale University at 1 site in United States.
Trial summary
The main purpose of this study is to develop sensitive radiographic measurement techniques that can be used as outcome measures along with patient-reported outcome instruments in clinical trials of calcinosis cutis treatments, and potentially be used to assess disease course and treatment response in clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc), Calcinosis Cutis
- What is being tested?
- Sodium Thiosulfate (STS) and Sodium Thiosulfate Injection
- Type of treatment
- Injection or infusion
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adults with SSc with clinically apparent calcinosis cutis on physical exam will be recruited from Yale clinics.
Who may be able to join
- Scleroderma/systemic sclerosis patient with diagnosed calcinosis cutis who will be clinically treated with STS as they would in clinical SOC care
- Must be ≥ 18 years old and meet the 2013 American College of Rheumatology criteria for the diagnosis of systemic sclerosis (diffuse or limited)
- Receiving clinical care at Yale clinics
Who cannot join
- Unable to provide informed consent
- Currently pregnant or nursing
- Patients with a calcinosis ROI >6cm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Diane Documet contact
United States1 site, 1 recruiting
- Recruiting
Yale Scleroderma Program
New Haven, Connecticut, 06520
About this study
Official title: Quantification of Calcinosis Cutis Disease Burden in Patients With Systemic Sclerosis Using Computed Tomography Images
The main purpose of this study is to develop sensitive radiographic measurement techniques that can be used as outcome measures along with patient-reported outcome instruments in clinical trials of calcinosis cutis treatments, and potentially be used to assess disease course and treatment response in clinical practice. The goal is to test the performance of the software.
- Conditions
- Systemic Sclerosis (SSc), Calcinosis Cutis
- Being tested
- Sodium Thiosulfate (STS), Sodium Thiosulfate Injection
- Medical subject headings
- Scleroderma, Systemic, Calcinosis Cutis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Thiosulfate (STS)Drug
Calcinosis cutis treatment, 25% STS topical cream, Twice daily for 6 months
Sodium Thiosulfate InjectionDrug
calcinosis cutis treatment, 25% STS intradermal injection, once monthly for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Systemic sclerosis participants with calcinosis | SSc participants with calcinosis treated with sodium thiosulfate STS per SOC over 6 months. Receives: Drug: Sodium Thiosulfate (STS); Drug: Sodium Thiosulfate Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Mawdsley Calcinosis Questionnaire (mMCQ)
An 18-question survey with an overall score of 0-10; each individual question ranges from 0-10, scores are totaled and averaged to and divided by 18 to create the overall score. Higher scores indicate higher disability from calcinosis.
Measured: Baseline, 3 months and 6 months
Calcinosis VAS
Used to measure the severity of calcinosis-related pain or symptoms. Scored 0-100 with higher scores indicating greater severity.
Measured: Baseline, 3 months and 6 months
CT imaging measure
BioImageSuite Web will be used to measure the CT scan volumes. The measurements are quantified using voxel annotation and built-in computation software. The volume of each scan will be recorded.
Measured: Baseline, 3 months and 6 months
Secondary outcomes (1)
Correlation between the change in the mMCQ scores and the CT imaging measures
Correlation between the change in the mMCQ scores (An 18-question survey with an overall score of 0-10; each individual question ranges from 0-10, scores are totaled and averaged to and divided by 18 to create the overall score) and the CT imaging measures (BioImageSuite Web will be used to measure the CT scan volumes. The measurements are quantified using voxel annotation and built-in computation software.)
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start14 Oct 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
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 Yale UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Monique Hinchcliff, MD, MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228429
- Sponsor's protocol ID
- 2000040280
- Other IDs
- 1R01AR085316-01A1
- Status last verified
- Nov 2026
- First submitted
- 12 Nov 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Calcinosis Cutis Disease Burden in Patients With Systemic Sclerosis Using Computed Tomography Images
- ClinicalTrials.gov ID
- NCT07228429
- Acronym / sponsor ID
- 2000040280
- Conditions
- Systemic Sclerosis (SSc), Calcinosis Cutis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 14 Nov 2025 (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.
The main purpose of this study is to develop sensitive radiographic measurement techniques that can be used as outcome measures along with patient-reported outcome instruments in clinical trials of calcinosis cutis treatments, and potentially be used to assess disease course and treatment response in clinical practice. The goal is to test the performance of the software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic sclerosis participants with calcinosis | – | Drug: Sodium Thiosulfate (STS), Drug: Sodium Thiosulfate InjectionSSc participants with calcinosis treated with sodium thiosulfate STS per SOC over 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with SSc with clinically apparent calcinosis cutis on physical exam will be recruited from Yale clinics.
Key inclusion criteria (3 listed)
- Scleroderma/systemic sclerosis patient with diagnosed calcinosis cutis who will be clinically treated with STS as they would in clinical SOC care
- Must be ≥ 18 years old and meet the 2013 American College of Rheumatology criteria for the diagnosis of systemic sclerosis (diffuse or limited)
- Receiving clinical care at Yale clinics
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Currently pregnant or nursing
- Patients with a calcinosis ROI >6cm
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 |
|---|---|---|
| Sodium Thiosulfate (STS)Calcinosis cutis treatment, 25% STS topical cream, Twice daily for 6 months | Drug | Systemic sclerosis participants with calcinosis |
| Sodium Thiosulfate Injectioncalcinosis cutis treatment, 25% STS intradermal injection, once monthly for 6 months | Drug | Systemic sclerosis participants with calcinosis |
Primary outcome
Modified Mawdsley Calcinosis Questionnaire (mMCQ)
Time frame: Baseline, 3 months and 6 months
An 18-question survey with an overall score of 0-10; each individual question ranges from 0-10, scores are totaled and averaged to and divided by 18 to create the overall score. Higher scores indicate higher disability from calcinosis.
Calcinosis VAS
Time frame: Baseline, 3 months and 6 months
Used to measure the severity of calcinosis-related pain or symptoms. Scored 0-100 with higher scores indicating greater severity.
CT imaging measure
Time frame: Baseline, 3 months and 6 months
BioImageSuite Web will be used to measure the CT scan volumes. The measurements are quantified using voxel annotation and built-in computation software. The volume of each scan will be recorded.
1 secondary outcome
Correlation between the change in the mMCQ scores and the CT imaging measures
Time frame: Baseline, 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Diane Documet contact
Monique Hinchcliff, MD, MS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis (SSc) and Calcinosis Cutis, run by Yale University at 1 site in United States.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal Cheung (203-737-5571, crystal.cheung@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Mawdsley Calcinosis Questionnaire (mMCQ) (time frame: Baseline, 3 months and 6 months). The study lists 3 primary outcomes in all. 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 4 Nov 2026.