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Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

Recruitingn/aAges 18 Years - anyAllYale University
NCT07228429 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Sodium Thiosulfate (STS)
  • Sodium Thiosulfate Injection
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Where

1 site
Yale Scleroderma Program
New Haven, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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