Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

Yale University56 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Systemic Sclerosis (SSc)Calcinosis Cutis

Interventions

Sodium Thiosulfate (STS)DRUG

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

Sodium Thiosulfate InjectionDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale Scleroderma Program

New Haven, Connecticut, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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

Central Contacts

Crystal Cheung

CONTACT

203-737-5571 crystal.cheung@yale.edu

Diane Documet

CONTACT

diane.documet@yale.edu

Data from ClinicalTrials.gov

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