Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

Quantification of Calcinosis Cutis Disease Burden in Patients With Systemic Sclerosis Using Computed Tomography Images

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.

Study Overview

• Status: Recruiting
• Conditions: Calcinosis Cutis; Systemic Sclerosis (SSc)
• Intervention / Treatment: Drug: Sodium Thiosulfate (STS); Drug: Sodium Thiosulfate Injection

• Study Type: Observational
• Enrollment (Estimated): 56

Contacts and Locations

• Study Contact: Name: Crystal Cheung; Phone Number: 203-737-5571; Email: crystal.cheung@yale.edu
• Study Contact Backup: Name: Diane Documet; Email: diane.documet@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale Scleroderma Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults with SSc with clinically apparent calcinosis cutis on physical exam will be recruited from Yale clinics.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Systemic sclerosis participants with calcinosis; SSc participants with calcinosis treated with sodium thiosulfate STS per SOC over 6 months.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Mawdsley Calcinosis Questionnaire (mMCQ)	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.	Baseline, 3 months and 6 months
CT imaging measure	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.	Baseline, 3 months and 6 months
Calcinosis VAS	Used to measure the severity of calcinosis-related pain or symptoms. Scored 0-100 with higher scores indicating greater severity.	Baseline, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the change in the mMCQ scores and the CT imaging measures	Correlation between the change in the mMCQ scores (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) and the CT imaging measures (BioImageSuite Web will be used to measure the CT scan volumes. The measurements are quantified using voxel annotation and built-in computation software.)	Baseline, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Monique Hinchcliff, MD, MS, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 12, 2025
• First Submitted That Met QC Criteria: November 12, 2025
• First Posted (Actual): November 14, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Connective Tissue Diseases; Skin Diseases; Calcium Metabolism Disorders; Calcinosis; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Calcinosis Cutis; Scleroderma, Systemic; sodium thiosulfate
• Other Study ID Numbers: 2000040280; 1R01AR085316-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No