Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
2 other identifiers
observational
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2025
CompletedFirst Submitted
Initial submission to the registry
November 12, 2025
CompletedFirst Posted
Study publicly available on registry
November 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
February 17, 2026
February 1, 2026
9 months
November 12, 2025
February 11, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Secondary Outcomes (1)
Correlation between the change in the mMCQ scores and the CT imaging measures
Baseline, 3 months and 6 months
Study Arms (1)
Systemic sclerosis participants with calcinosis
SSc participants with calcinosis treated with sodium thiosulfate STS per SOC over 6 months.
Interventions
Calcinosis cutis treatment, 25% STS topical cream, Twice daily for 6 months
calcinosis cutis treatment, 25% STS intradermal injection, once monthly for 6 months
Eligibility Criteria
Adults with SSc with clinically apparent calcinosis cutis on physical exam will be recruited from Yale clinics.
You may qualify if:
- 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
You may not qualify if:
- Unable to provide informed consent
- Currently pregnant or nursing
- Patients with a calcinosis ROI \>6cm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yale Scleroderma Program
New Haven, Connecticut, 06520, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monique Hinchcliff, MD, MS
Yale University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2025
First Posted
November 14, 2025
Study Start
October 14, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share