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Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

ConditionsSystemic Sclerosis (SSc)Calcinosis Cutis
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

This trial does not accept healthy volunteers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sodium Thiosulfate (STS)

    Drug

    Calcinosis cutis treatment, 25% STS topical cream, Twice daily for 6 months

  • Sodium Thiosulfate Injection

    Drug

    calcinosis cutis treatment, 25% STS intradermal injection, once monthly for 6 months

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: Systemic sclerosis participants with calcinosis2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 3 months and 6 months
2

Calcinosis VAS

Used to measure the severity of calcinosis-related pain or symptoms. Scored 0-100 with higher scores indicating greater severity.

Time frame
Baseline, 3 months and 6 months
3

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.

Time frame
Baseline, 3 months and 6 months

Secondary outcomes

1

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.)

Time frame
Baseline, 3 months and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Source ClinicalTrials.gov
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