Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT07001059
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013700', 'term': 'Giant Cell Arteritis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess whether the Optic Nerve Sheath Diameter (ONSD) measured by orbital ultrasound serves as an effective diagnostic marker for Giant Cell Arteritis (GCA)', 'timeFrame': 'At the patient enrollment visit and at 6 months', 'description': "Area under the ROC curve (AUC) of the optic nerve sheath measurements obtained by ultrasound during the enrollment phase, using the final clinical expert diagnosis at 6 months as the reference standard.\n\nThe clinical expert's evaluation will be blinded to the optic nerve sheath measurements."}], 'secondaryOutcomes': [{'measure': 'Assess the reproducibility of the optic nerve sheath diameter (ONSD) measurements by ultrasound.', 'timeFrame': 'At the patient enrollment visit and at 6 months', 'description': 'Mean bias according to Bland-Altman analysis, limits of agreement with their confidence intervals, maximum acceptable difference (clinical and statistical difference calculated using the root sum of squares of the coefficients of variation), inter-rater ICC.'}, {'measure': 'Evaluate the diagnostic performance of ONSD in GCA.', 'timeFrame': 'At the patient enrollment visit and at 6 months', 'description': 'Sensitivity, specificity, ROC curve inflection point (pathological threshold value), positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio.'}, {'measure': 'Study the evolution of ONSD under treatment between M0 and M6 in patients with GCA.', 'timeFrame': 'At the patient enrollment visit and at 6 months', 'description': 'Measurement of the optic nerve sheath diameter (ONSD) by ultrasound at baseline (within 3 days of corticosteroid initiation) in all patients, and at 6 months in patients with GCA.'}, {'measure': 'Exploratory evaluation of ONSD according to the presence or absence of extracranial GCA.', 'timeFrame': 'At the patient enrollment visit and at 6 months', 'description': 'Comparison of mean ONSD between subgroups: cranial GCA, extracranial GCA, and GCA-negative patients.'}, {'measure': 'Exploratory evaluation of ONSD based on the presence or absence of GCA with visual involvement.', 'timeFrame': 'At the patient enrollment visit and at 6 months', 'description': 'Comparison of mean ONSD between subgroups: GCA with visual involvement, GCA without visual involvement, and GCA-negative patients'}, {'measure': 'Assess the feasibility of ultrasound as a diagnostic tool for GCA.', 'timeFrame': 'At the patient enrollment visit and at 6 months', 'description': 'Description of the patient flow : average duration of the exam'}, {'measure': 'Assess the feasibility of ultrasound as a diagnostic tool for GCA.', 'timeFrame': 'At the patient enrollment visit and at 6 months', 'description': 'Description of the patient flow : percentage of exams performed, and percentage of interpretable exams.'}, {'measure': 'Assess the feasibility of ultrasound as a diagnostic tool for GCA.', 'timeFrame': 'At the patient enrollment visit and at 6 months', 'description': 'Description of the patient flow : number of exams performed, and number of interpretable exams.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Giant Cell Arteritis', 'Optic nerve sheath', 'Ultrasound'], 'conditions': ['Giant Cell Arteritis (GCA)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether the measure of the optic nerve sheath is a reliable diagnostic marker for giant cell arteritis', 'detailedDescription': 'Giant Cell Arteritis (GCA) is a vasculitis affecting large and medium-sized vessels. It predominantly occurs in women, with a sex ratio of 3:1, and mainly affects individuals around 70 years of age. GCA is a rare condition, with an incidence of approximately 10 cases per 100,000 people in France.\n\nCurrent recommendations suggest using imaging techniques and/or temporal artery biopsy (TAB) based on the clinical resources available. The key challenge in suspected cases of GCA is to establish a rapid diagnosis.\n\nIt is important to note that false-negative imaging results may occur if corticosteroid treatment is initiated prior to imaging: after 3 days for PET-CT, 5 to 7 days for Doppler ultrasound, and up to 14 days for TAB.\n\nDiagnosing GCA is not always easy and depends on depends on the prompt performance of complementary examinations. Studies have shown that the optic nerve sheath is thickened on ultrasound in patients with GCA. In this context, the investigator aims to evaluate the measurement of the optic nerve sheath via ultrasound for diagnosing GCA. Ultrasound offers a faster, non-invasive, widely available, and cost-effective diagnostic tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with suspected GCA\n* Patient over 50 years\n\nExclusion Criteria:\n\n* Patient with history of GCA\n* Patient with a history of polymyalgia rheumatic (PMR) without initial PET scan\n* Patient with a history of retinal disease, demyelinating disease, or intracranial hypertension\n* Use of corticosteroids \\> 0.5mg/kg in the last 2 weeks'}, 'identificationModule': {'nctId': 'NCT07001059', 'acronym': 'PETRUS', 'briefTitle': 'oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital NOVO'}, 'officialTitle': 'oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound', 'orgStudyIdInfo': {'id': 'CHRD 0524'}, 'secondaryIdInfos': [{'id': '2025-A00141-48', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orbital ultrasounds', 'description': 'Orbital ultrasounds on patients suspected of GCA at the enrollment (M0) and at 6 months if the suspicion of GCA is confirmed after all the tests realized at the enrollment.', 'interventionNames': ['Diagnostic Test: orbital ultrasound']}], 'interventions': [{'name': 'orbital ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'orbital ultrasound at the beginning of the participation, and at 6 months after the inclusion.', 'armGroupLabels': ['Orbital ultrasounds']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aix-en-Provence', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'François VIDAL, Dr', 'role': 'CONTACT', 'email': 'fvidal@ch-aix.fr', 'phone': '+33442335049'}], 'facility': 'Rhumatology departement - Centre Hospitalier Aix en Provence', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Brest', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Baptiste QUERE, Dr', 'role': 'CONTACT', 'email': 'baptiste.quere@chu-brest.fr', 'phone': '+33 2 98 22 33 33'}], 'facility': 'Rhumatology department - Centre Hospitalier Universitaire de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jonathan BOUTEMY, Dr', 'role': 'CONTACT', 'email': 'boutemy-j@chu-caen.fr', 'phone': '+33231064579'}], 'facility': 'Internal Medecine Department- CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Dijon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maxime SAMSON, Dr', 'role': 'CONTACT', 'email': 'maxime.samson@chu-dijon.fr', 'phone': '+33 3 80 29 34 32'}], 'facility': 'Internal Medicine and Clinical Immulogy department - Centre Hospitalier Universitaire de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier ESPITIA, Dr', 'role': 'CONTACT', 'email': 'Olivier.ESPITIA@chu-nantes.fr', 'phone': '+33 2 40 08 33 55'}], 'facility': 'Internal Medicine and VascularMedecine Department - Centre Hospitalier Universitaire de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Etienne GHRENASSIA, Dr', 'role': 'CONTACT', 'email': 'etienne.ghrenassia@aphp.fr', 'phone': '+33 1 71 97 05 06'}], 'facility': 'Internal Medicine department - Hôpital Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sébastien OTTAVIANI, Dr', 'role': 'CONTACT', 'email': 'sebastien.ottaviani@aphp.fr', 'phone': '+33 1 40 25 70 27'}], 'facility': 'Rhumatology department - Hôpital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pontoise', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Omar AL TABAA, Dr', 'role': 'CONTACT', 'email': 'omar.altabaa@ght-novo.fr', 'phone': '+33130755226'}], 'facility': 'Rhumatology department - Hôpital NOVO - Pontoise site', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'city': 'Tours', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume CARVAJAL, Dr', 'role': 'CONTACT', 'email': 'guillermo.carvajal@univ-tours.fr', 'phone': '+33 2 47 47 47 47'}], 'facility': 'Rhumatology department - Centre Hospitalier Universitaire de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Maryline DELATTRE', 'role': 'CONTACT', 'email': 'maryline.delattre@ght-novo.fr', 'phone': '+330130754131'}, {'name': 'Mathilde WLODARCZYK', 'role': 'CONTACT', 'email': 'mathilde.wlodarczyk@ght-novo.fr', 'phone': '+330130754040', 'phoneExt': '7199'}], 'overallOfficials': [{'name': 'Omar AL TABAA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital NOVO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital NOVO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}