Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

Yale University

Status: Not yet enrolling

Conditions: Calcinosis Cutis; Systemic Sclerosis (SSc)

Treatments: Drug: Sodium Thiosulfate (STS)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07228429

2000040280

1R01AR085316-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

56 participants in 1 patient group

Systemic sclerosis participants with calcinosis

Description:

SSc participants with calcinosis treated with sodium thiosulfate STS per SOC over 6 months.

Treatment:

Drug: Sodium Thiosulfate (STS)