NCT07228429Recruiting

Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

Yale University

Start Date

10/14/2025

Completion Date

7/1/2026

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

Age Range: 18 years to No maximum

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

DRUG

Sodium Thiosulfate (STS)

DRUG

Sodium Thiosulfate Injection

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Conditions

Systemic Sclerosis (SSc)Calcinosis Cutis

Locations

Yale Scleroderma Program

New Haven, Connecticut 06520

United States