Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sodium Thiosulfate (STS), Sodium Thiosulfate Injection.
- Who it may be relevant to
- Registry conditions: Systemic Sclerosis (SSc), Calcinosis Cutis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Quantification of Calcinosis Cutis Disease Burden in Patients With Systemic Sclerosis Using Computed Tomography Images
Overview
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.
Interventions
- Drug Sodium Thiosulfate (STS)
Calcinosis cutis treatment, 25% STS topical cream, Twice daily for 6 months - Drug Sodium Thiosulfate Injection
calcinosis cutis treatment, 25% STS intradermal injection, once monthly for 6 months
Primary outcome measures
- Modified Mawdsley Calcinosis Questionnaire (mMCQ) [Time frame: Baseline, 3 months and 6 months]
- Calcinosis VAS [Time frame: Baseline, 3 months and 6 months]
- CT imaging measure [Time frame: Baseline, 3 months and 6 months]
Secondary outcome measures (1)
- Correlation between the change in the mMCQ scores and the CT imaging measures [Time frame: Baseline, 3 months and 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Yale Scleroderma Program — New Haven
Identifiers
NCT: NCT07228429 · 2000040280 · 1R01AR085316-01A1