RecruitingNCT07228429

Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

Quantification of Calcinosis Cutis Disease Burden in Patients With Systemic Sclerosis Using Computed Tomography Images


Sponsor

Yale University

Enrollment

56 participants

Start Date

Oct 14, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

  • Unable to provide informed consent
  • Currently pregnant or nursing
  • Patients with a calcinosis ROI >6cm

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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


Locations(1)

Yale Scleroderma Program

New Haven, Connecticut, United States

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NCT07228429


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