Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-01 @ 3:35 PM
Study NCT ID:
NCT06847750
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-26
First Post:
2024-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elastography Ultrasound in Localized Scleroderma (Morphea) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin stiffness', 'timeFrame': 'Baseline, 3-6m and 9-12m', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Lesion activity responsiveness', 'timeFrame': 'Baseline, 3-6m and 9-12m', 'description': 'The LoSCAT (Localized Sclerodema Cutaneous Assessment Tool scores) assesses 18 cutaneous anatomic sites, capturing both disease activity (mLoSSI - Modified Localized Skin Severity Index) and disease damage (LoSDI - Localized Scleroderma Damage Index). Scores for each site are based on the most severe score for each parameter ranging from 0 to 3. A higher score represents a worse outcome.'}, {'measure': 'Echogenicity scores for dermis and hypodermis', 'timeFrame': 'Baseline, 3-6m and 9-12m', 'description': 'Standard ultrasound protocol. Identifying sonographic changes in the involved body site will be accomplished by comparing both echogenicity and color Doppler signal to a corresponding normal site. The score is determined by summing the absolute value of the individual parameters, with a range from 0 to 15 (maximum echogenicity score of 6, maximum vascularity score of 9). A higher score represents a worse outcome.'}, {'measure': 'Vascularity scores for dermis and hypodermis', 'timeFrame': 'Baseline, 3-6m and 9-12m', 'description': 'Doppler Ultrasound protocol. Identifying sonographic changes in the involved body site will be accomplished by comparing both echogenicity and color Doppler signal to a corresponding normal site. The score is determined by summing the absolute value of the individual parameters, with a range from 0 to 15 (maximum echogenicity score of 6, maximum vascularity score of 9). A higher score represents a worse outcome.'}, {'measure': 'Quality of Life', 'timeFrame': 'Baseline, 3-6m and 9-12m', 'description': 'Completiom of the LoSQI (Localized Scleroderma Quality of Life Instrument), a self-reported disease-specific questionnaire to assess the quality of life of patients (children, adolescents and young adults) with localized scleroderma. It consists of 21 items across three theoretical domains: (1) skin sensations, (2) physical functioning and musculoskeletal sequelae, and (3) body image and social support. Scores are based on the most severe score for each parameter ranging from 0 to 3.\n\nThe questionnaire includes questions that comprise the Pain \\& Physical Functioning subscale, and the Body Image \\& Social Support subscale. Scores are summoned and converted to a scale, ranging from 41.3 to 71.6 and 43.58 to 68.42, respectively.\n\nA higher score represents a worse outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elastography ultrasound', 'Scleroderma', 'Quality of Life', 'Pediatric'], 'conditions': ['Scleroderma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://carragroup.org/grant/elastography-ultrasound-in-localized-scleroderma-morphea-a-prospective-longitudinal-multicentric-pilot-study-2/', 'label': 'CARRA is a registered non-profit organization. Its mission is to conduct collaborative research to prevent, treat and cure pediatric rheumatic diseases.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diagnosis of LS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n* Able to cooperate with clinical and US evaluation, and the parent or guardian is able to fill out interim patient history form.\n\nExclusion Criteria:\n\n* Patients with other co-morbidities (e.g. systemic sclerosis, juvenile idiopathic arthritis, other systemic diseases).\n* Patients who present with one active and one inactive lesion.\n* Patients with lesions located in the face or head.'}, 'identificationModule': {'nctId': 'NCT06847750', 'briefTitle': 'Elastography Ultrasound in Localized Scleroderma (Morphea) Study', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Elastography Ultrasound in Localized Scleroderma (Morphea): a Prospective, Longitudinal, Multicentric Pilot Study', 'orgStudyIdInfo': {'id': '1000078198'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elastography group', 'description': '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.', 'interventionNames': ['Diagnostic Test: Elastography Ultrasound', 'Other: The Localized Scleroderma Quality of Life Instrument (LoSQI )']}], 'interventions': [{'name': 'Elastography Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'The US imaging protocol will include three parts: (i) gray-scale; (ii) color Doppler, and (iii) Shear-wave elastography (SWE)', 'armGroupLabels': ['Elastography group']}, {'name': 'The Localized Scleroderma Quality of Life Instrument (LoSQI )', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Elastography group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'collaborators': [{'name': 'Childhood Arthritis and Rheumatology Research Alliance', 'class': 'OTHER'}, {'name': "Joseph Sanzari Children's Hospital", 'class': 'UNKNOWN'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Vice-Chair of Radiology (Clinical Practice Improvement), Department of Medical Imaging, University of Toronto Radiologist, Senior Scientist, Research Director, Department of Diagnostic Imaging', 'investigatorFullName': 'Andrea Doria', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}