Elastography Ultrasound in Localized Scleroderma (Morphea) Study

NCT06847750 | Enrolling By Invitation

• 1 other identifier: 1000078198
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Localized scleroderma (LS) is a skin disease that can cause complications such as disfigurement and limitation of mobility. Treatment for LS should be initiated early in the disease, as late-stage scleroderma does not respond well to treatment. Objective tools for diagnosis and follow-up of treatment for LS are not available clinically and are urgently needed. A new non-invasive ultrasound technique called "elastography" measures stiffness of tissues and holds potential for providing objective measures for follow-up of treatment of LS in children and adolescents. The team plans to conduct a multicenter study in North America to determine whether elastography ultrasound can show changes in skin stiffness for a period of 9 to 12 months after initiation of treatment for LS. This novel technology may add information to the existing imperfect clinical tools, thus improving the way therapy is offered to patients with LS.

Conditions

Scleroderma

Keywords

Elastography ultrasound; Scleroderma; Quality of Life; Pediatric

Outcome Measures

Primary Outcomes (1)

• Skin stiffness

  Skin stiffness will be assessed using Elastography (SWE) Ultrasound, a sonographic technique that uses mechanical waves to assess tissue elasticity and display it in a quantitative manner. The stiffness of the tissue is directly proportional to its shear wave velocity. SWE will measure interval changes of skin stiffness during treatment at the target lesion and the unaffected contralateral site.

  Baseline, 3-6m and 9-12m

Secondary Outcomes (4)

• Lesion activity responsiveness

  Baseline, 3-6m and 9-12m

• Echogenicity scores for dermis and hypodermis

  Baseline, 3-6m and 9-12m

• Vascularity scores for dermis and hypodermis

  Baseline, 3-6m and 9-12m

• Quality of Life

  Baseline, 3-6m and 9-12m

Study Arms (1)

Elastography group

Boys and girls 0-18 years of age at the time of disease onset with a new or existing diagnosis of localized scleroderma will have a physical examination and elastogrpahy ultrasound at specific timepoints, based on the timeframe for clinical visits. A questionnaire will be administered by the time of each study visit.

Diagnostic Test: Elastography Ultrasound; Other: The Localized Scleroderma Quality of Life Instrument (LoSQI )

Interventions

Elastography Ultrasound DIAGNOSTIC_TEST

The US imaging protocol will include three parts: (i) gray-scale; (ii) color Doppler, and (iii) Shear-wave elastography (SWE)

Elastography group

The Localized Scleroderma Quality of Life Instrument (LoSQI ) OTHER

The questionnaire is a validated disease-specific patient-reported outcome measure that covers different domains (skin sensations, physical functioning, body image and social support, designed for children and adolescents with localized scleroderma

Elastography group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with diagnosis of LS

You may qualify if:

• Boys and girls 0-18 years of age at the time of disease onset with a new or existing diagnosis of localized scleroderma (LS) confirmed by a pediatric rheumatologist or dermatologist.
• Presents with one active or inactive lesion, using the contralateral site for comparison at each visit, as long as the same lesion is evaluated at each time point. OR Presents with more than one lesion as far as both lesions are active or inactive.
• Able to cooperate with clinical and US evaluation, and the parent or guardian is able to fill out interim patient history form.

You may not qualify if:

• Patients with other co-morbidities (e.g. systemic sclerosis, juvenile idiopathic arthritis, other systemic diseases).
• Patients who present with one active and one inactive lesion.
• Patients with lesions located in the face or head.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Childhood Arthritis and Rheumatology Research Alliance: collaborator
• Joseph Sanzari Children's Hospital: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Links

• CARRA is a registered non-profit organization. Its mission is to conduct collaborative research to prevent, treat and cure pediatric rheumatic diseases.

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice-Chair of Radiology (Clinical Practice Improvement), Department of Medical Imaging, University of Toronto Radiologist, Senior Scientist, Research Director, Department of Diagnostic Imaging

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: February 26, 2025
• Study Start: March 10, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CA (1)