Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYale University
About this trial
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
Qualifiers
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
Disqualifiers
Unable to provide informed consent
Currently pregnant or nursing
Patients with a calcinosis ROI >6cm
Trial design
Treatments tested in this trial
- Sodium Thiosulfate (STS)
- Sodium Thiosulfate Injection
Treatment groups
56 Participants
are divided into 1 treatment groupSponsors and collaborators
Yale University
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov