RecruitingNot Applicable

Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

United States56 participantsStarted 2025-10-14

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Modified Mawdsley Calcinosis Questionnaire (mMCQ)

Timeframe: Baseline, 3 months and 6 months

Calcinosis VAS

Timeframe: Baseline, 3 months and 6 months

CT imaging measure

Timeframe: Baseline, 3 months and 6 months

Trial details

NCT IDNCT07228429

SponsorYale University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07

Contact for this trial

Crystal Cheung

203-737-5571 crystal.cheung@yale.edu

View on ClinicalTrials.gov More Systemic Sclerosis (SSc) trials