Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

Not yet recruiting

• Conditions: Systemic Sclerosis (SSc); Calcinosis Cutis
• Interventions: Drug: Sodium Thiosulfate (STS)

• Registration Number: NCT07228429
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study Start: 2025-11-01
• Study First Submitted: 2025-11-12
• Study First Submitted QC: 2025-11-12
• Last Update Submitted: 2025-11-12
• Study First Posted: 2025-11-14
• Last Update Posted: 2025-11-14
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Systemic sclerosis participants with calcinosis	Sodium Thiosulfate (STS)	SSc participants with calcinosis treated with sodium thiosulfate STS per SOC over 6 months.

Primary Outcome Measures

Name	Time	Method
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 VAS	Baseline, 3 months and 6 months	Used to measure the severity of calcinosis-related pain or symptoms. Scored 0-100 with higher scores indicate
CT imaging measure	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Association between the change in the mMCQ scores and the CT imaging measures	Baseline, 3 months and 6 months	Association between the change in the mMCQ scores and the CT imaging measures will be assessed

Trial Locations

Locations (1)

Yale Scleroderma Program; 🇺🇸 New Haven, Connecticut, United States