Quantification of Calcinosis Cutis Disease Burden in Patients With Systemic Sclerosis Using Computed Tomography Images
Yale University
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 practice. The goal is to test the performance of the software.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugSodium Thiosulfate (STS)
Calcinosis cutis treatment, 25% STS topical cream, Twice daily for 6 months
- DrugSodium Thiosulfate Injection
calcinosis cutis treatment, 25% STS intradermal injection, once monthly for 6 months
Location
- Yale Scleroderma ProgramNew Haven, Connecticut