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RecruitingNCT07228429

Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

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Trial Parameters

ConditionSystemic Sclerosis (SSc)
SponsorYale University
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment56
SexALL
Min Age18 Years
Max AgeN/A
Start Date2025-10-14
Completion2026-07
Interventions
Sodium Thiosulfate (STS)Sodium Thiosulfate Injection

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Brief 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 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

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