Observational Study on Calcinosis Cutis Imaging
This study aims to improve how we measure calcinosis cutis (calcium deposits under the skin) in people with Systemic Sclerosis (SSc). Researchers are looking at how well special software can measure these deposits using CT scans. You might be eligible if you have Systemic Sclerosis with calcinosis cutis, are at least 18 years old, and are already receiving treatment with Sodium Thiosulfate (STS) topical cream or injections at Yale clinics. The study will track changes in your calcinosis using questionnaires and CT scans over 6 months to see if the software can accurately show disease changes and treatment response. The current recruitment status is unclear.
- Study design
- This is an observational study with a planned enrollment of 56 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would have CT scans and complete questionnaires at the start, 3 months, and 6 months. You would also be receiving Sodium Thiosulfate treatment (topical cream twice daily or injections once monthly) for 6 months as part of your usual care.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your calcinosis will be measured at baseline, 3 months, and 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Monique Hinchcliff, MD, MS · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Modified Mawdsley Calcinosis Questionnaire (mMCQ)Baseline, 3 months and 6 months
An 18-question survey with an overall score of 0-10; each individual question ranges from 0-10, scores are totaled and averaged to and divided by 18 to create the overall score. Higher scores indicate higher disability from calcinosis.
- Calcinosis VASBaseline, 3 months and 6 months
Used to measure the severity of calcinosis-related pain or symptoms. Scored 0-100 with higher scores indicating greater severity.
- CT imaging measureBaseline, 3 months and 6 months
BioImageSuite Web will be used to measure the CT scan volumes. The measurements are quantified using voxel annotation and built-in computation software. The volume of each scan will be recorded.