Measuring calcinosis cutis burden on CT scans
Official title: Quantification of Calcinosis Cutis Disease Burden in Patients With Systemic Sclerosis Using Computed Tomography Images
Run by Yale University · NCT07228429 · Data updated 2026-11-12
This project will test software that measures calcinosis cutis on CT images for adults with systemic sclerosis who are receiving sodium thiosulfate as part of their care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Status | Recruiting |
| Started | October 14, 2025 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07228429 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with systemic sclerosis and diagnosed calcinosis cutis who are receiving sodium thiosulfate as part of routine care at Yale are the ideal candidates.
✕Probably not a fit
People who are unable to give consent, are pregnant or nursing, have a calcinosis lesion larger than 6 cm in a region of interest, or who are not treated at Yale are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational effort aims to develop and test radiographic measurement techniques that quantify calcinosis cutis using computed tomography images. The software's performance will be compared with clinical information and patient-reported outcome instruments to determine its sensitivity for tracking disease burden and change over time. Participants are adults with systemic sclerosis and diagnosed calcinosis cutis who will receive sodium thiosulfate as part of standard clinical care at Yale. Imaging and analysis will focus on defined regions of interest and exclude lesions larger than 6 cm in a single ROI.
Why it matters
Potential benefit: If successful, the software could provide an objective, reproducible imaging measure to track calcinosis progression and treatment response.
How similar studies have gone: Small prior reports have used CT to visualize calcinosis, but standardized, validated software quantification methods are limited, so this is a relatively novel validation effort.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Unable to provide informed consent * Currently pregnant or nursing * Patients with a calcinosis ROI \>6cm
Where it's running
-
Yale Scleroderma Program
New Haven, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Monique Hinchcliff, MD, MS — Yale University
- Study coordinator: Crystal Cheung
- Email: crystal.cheung@yale.edu
- Phone: 203-737-5571
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.