Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

NCT ID: NCT07228429

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Systemic Sclerosis (SSc) Calcinosis Cutis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Systemic sclerosis participants with calcinosis

SSc participants with calcinosis treated with sodium thiosulfate STS per SOC over 6 months.

Sodium Thiosulfate (STS)

Intervention Type DRUG

Calcinosis cutis treatment , Twice daily for 6 months

Interventions

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Sodium Thiosulfate (STS)

Calcinosis cutis treatment , Twice daily for 6 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monique Hinchcliff, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale Scleroderma Program

New Haven, Connecticut, United States

Site Status

Countries

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United States

Central Contacts

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Crystal Cheung

Role: CONTACT

203-737-5571

Diane Documet

Role: CONTACT

Other Identifiers

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1R01AR085316-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000040280

Identifier Type: -

Identifier Source: org_study_id

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