Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT05749094
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2023-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013700', 'term': 'Giant Cell Arteritis'}, {'id': 'D018917', 'term': 'Optic Neuropathy, Ischemic'}], 'ancestors': [{'id': 'D020293', 'term': 'Vasculitis, Central Nervous System'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001167', 'term': 'Arteritis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 285}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2023-02-18', 'studyFirstSubmitQcDate': '2023-02-18', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intra- and Inter- observer reliability', 'timeFrame': 'Baseline', 'description': 'Intra- and interobserver reliability of ONSD measurements'}, {'measure': 'Association between ONSD and Retinal Changes', 'timeFrame': 'Up to 2 years', 'description': 'The association between ONSD and the presence/absence of GCA-related retinal findings on digital fundoscopy in patients with GCA.'}], 'primaryOutcomes': [{'measure': 'Diagnostic performance of ONSD to identify new-onset GCA', 'timeFrame': 'Baseline', 'description': 'The primary outcome of SONIC-GCA is to determine the optimal ONSD cutoff for identifying GCA at the baseline visit and to assess its diagnostic performance, including sensitivity, specificity, positive and negative predictive values, and accuracy.'}, {'measure': 'ONSD in patients with and without GCA', 'timeFrame': 'Baseline', 'description': 'At baseline, ONSD measurements (in mm) of the left and right eyes of each participant will be recorded and used to calculate the mean ONSD for patients with and without GCA.'}], 'secondaryOutcomes': [{'measure': 'ONSD changes over time', 'timeFrame': 'Up to 2 years', 'description': 'The main secondary outcome will determine whether ONSD dynamically correlates with relapse risk over the follow-up period in patients with GCA, providing insight into its potential as a biomarker for disease monitoring.'}, {'measure': 'The associations between ONSD changes and GCA relapses', 'timeFrame': 'Up to 2 years', 'description': 'The association between ONSD changes and GCA relapses will be assessed during the follow-up period, in patients with GCA.'}, {'measure': 'Evaluation of the performance of ONSD to detect a GCA relapse', 'timeFrame': 'Up to 2 years', 'description': 'We will assess the diagnostic performance of the initial ONSD cutoff (from the primary objective) at each follow-up visit to differentiate between relapse and remission. This analysis will determine whether the established cutoff remains a reliable marker for monitoring disease status in GCA over time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Giant Cell Arteritis', 'Anterior Ischemic Optic Neuropathy', 'Optic Neuropathy, Ischemic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://vasculitemontreal.com', 'label': 'Vasculitis Clinic - University of Montreal'}]}, 'descriptionModule': {'briefSummary': 'The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis (SONIC-GCA) study will evaluate the performance of the optic nerve sheath diameter (ONSD), measured via ultrasound, to diagnose and monitor GCA. SONIC-GCA builds upon our previous pilot studies and will answer the following questions:\n\n1. What is the performance of ONSD to identify patients with new-onset, active GCA?\n2. Is ONSD useful for monitoring GCA relapses during follow-up?\n3. What is the intra- and interobserver reliability of ONSD measurements?\n4. Does ONSD differ between patients with and without GCA-related retinal findings?', 'detailedDescription': 'SONIC-GCA is a prospective cohort and validation study conducted in centers of the Canadian Vasculitis Research Network (CanVasc).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive participants referred for suspected new-onset GCA.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Our population of interest is patients referred from any settings for suspected, new-onset GCA.\n\nInclusion criteria:\n\nTo be included in SONIC-GCA, participants must meet all the following criteria:\n\n1. Age \\> 50 years.\n2. Referral to a GCA clinic for suspected, new-onset GCA.\n3. Ability to understand and willingness to sign an informed consent form.\n4. Willingness to comply with study visits and procedures.\n\nExclusion criteria:\n\nAn individual who meets any of these criteria will be excluded from SONIC-GCA:\n\n1. Referral for a suspected GCA relapse.\n2. Current use of systemic glucocorticoids, with the following duration at the baseline visit: ≥ 14 consecutive days of oral glucocorticoids in the previous 30 days, or ≥ 7 consecutive days of oral glucocorticoids if intravenous glucocorticoids were administered in the previous 30 days.\n3. Current use of any conventional or biologic immunosuppressive therapy.\n4. Known previous medical history of retinal diseases, optic nerve diseases, demyelinating diseases, normotensive hydrocephalus, intracranial tumors (benign or malignant), or any conditions associated with intracranial hypertension.\n5. Any condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.'}, 'identificationModule': {'nctId': 'NCT05749094', 'acronym': 'SONIC-GCA', 'briefTitle': 'Optic Nerve Sheath Ultrasound in Giant Cell Arteritis', 'organization': {'class': 'OTHER', 'fullName': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal"}, 'officialTitle': 'The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis', 'orgStudyIdInfo': {'id': '20201890'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GCA group', 'description': 'Ascertainment of GCA will occur 6 months after study inclusion and will require all the following features: 1) initial symptoms and clinical evolution consistent with GCA; 2) at least one positive diagnostic test for GCA, including ultrasound of temporal arteries, temporal artery biopsy, cranial MRI or cranial PET; and 3) satisfies the 2022 ACR-EULAR classification criteria for GCA.\n\nStudy visits :\n\nBaseline - Month 3, 6, 12, 18 and 24 + relapse visit (if applicable)', 'interventionNames': ['Diagnostic Test: Optic nerve sheath ultrasound', 'Diagnostic Test: Standardized GCA assessment']}, {'label': 'Non-GCA group', 'description': 'Participants who do not meet the composite clinical test validation for GCA (above).\n\nStudy visits : Baseline and Month 6 (phone follow-up)', 'interventionNames': ['Diagnostic Test: Optic nerve sheath ultrasound', 'Diagnostic Test: Standardized GCA assessment']}], 'interventions': [{'name': 'Optic nerve sheath ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'The patients are examined in a supine relaxed position. The probe is gently placed on the closed eyelid with a standard ultrasound gel and adjusted to a suitable angle to display the optic nerve entry into the eyeball. Measurements are done 3mm distal to the posterior aspect of the ocular globe. Ultrasosonographic 14L5 probe is used with a safe thermal index, mechanical index and intensity limit. All patients will also undergo a bedside fundoscopic examination. Official ophthalmology consultation will be requested in patients with visual symptoms or abnormal fundoscopy.', 'armGroupLabels': ['GCA group', 'Non-GCA group']}, {'name': 'Standardized GCA assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Clinical assesment, blood test review, temporal/axillary artery ultrasound', 'armGroupLabels': ['GCA group', 'Non-GCA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Lillian Barra', 'role': 'CONTACT', 'email': 'lillian.barra@sjhc.london.on.ca', 'phone': '519-646-6100'}], 'facility': "St-Joseph's Health Care London", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Christian Pagnoux', 'role': 'CONTACT', 'email': 'Christian.pagnoux@sinaihealth.ca', 'phone': '416-596-4200'}], 'facility': 'Sinai Health - Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Arielle Mendel', 'role': 'CONTACT', 'email': 'arielle.mendel@mcgill.ca', 'phone': '4388556233'}], 'facility': 'MUHC - McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jean-Paul Makhzoum, MD, MSc', 'role': 'CONTACT', 'email': 'jean-paul.makhzoum@umontreal.ca'}, {'name': 'Guylaine Marcotte', 'role': 'CONTACT', 'email': 'guylaine.marcotte.cnmtl@ssss.gouv.qc.ca'}, {'name': 'Jean-Paul Makhzoum, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4R 3K6', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Roger Yang', 'role': 'CONTACT', 'email': 'roger.yang.med@ssss.gouv.qc.ca', 'phone': '514-252-3400'}], 'facility': "CIUSSS de l'Est-de-l'ile de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H1T 2M4', 'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Patrick Liang', 'role': 'CONTACT', 'email': 'rhumatoens-med@USherbrooke.ca', 'phone': '819-346-1110'}], 'facility': "CIUSSS de l'Estrie - CHUS", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'centralContacts': [{'name': 'Jean-Paul Makhzoum, MD', 'role': 'CONTACT', 'email': 'jean-paul.makhzoum@umontreal.ca', 'phone': '5143382222', 'phoneExt': '2725'}], 'overallOfficials': [{'name': 'Jean-Paul Makhzoum, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal", 'class': 'OTHER'}, 'collaborators': [{'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, {'name': "Ciusss de L'Est de l'Île de Montréal", 'class': 'OTHER'}, {'name': 'Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke', 'class': 'OTHER'}, {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}, {'name': "St. Joseph's Health Care London", 'class': 'OTHER'}, {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director - Vasculitis Research Program, Principal Investigator', 'investigatorFullName': 'Jean-Paul Makhzoum', 'investigatorAffiliation': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal"}}}}