Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT04874558
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2021-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultra-low-dose Chest CT for HHT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013683', 'term': 'Telangiectasia, Hereditary Hemorrhagic'}], 'ancestors': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013684', 'term': 'Telangiectasis'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultra-low dose images PAVM detection', 'timeFrame': 'Baseline', 'description': 'Number of images detecting PAVM using the ultra-low dose images (50% or lower compared to the full dose)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hereditary Hemorrhagic Telangiectasia']}, 'descriptionModule': {'briefSummary': 'This study aims to develop a novel ultra-low dose chest CT technology for use in Hereditary Hemorrhagic Teleangiectasia (HHT) patients and to determine the lowest possible radiation dose that is achievable without sacrificing the diagnostic quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients followed by HHT clinic who are ordered a chest CTA.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 1 to 17 years\n* Diagnosed with positive HHT causing mutations or based on Curacao criteria\n\nExclusion Criteria:\n\n* Acute respiratory distress\n* Unstable cardiovascular status\n* Pneumothorax, hemoptysis\n* Pulmonary edema\n* Pulmonary emboli\n* Fractured ribs or other chest trauma\n* Recent bronchoscopy\n* Lung transplantation'}, 'identificationModule': {'nctId': 'NCT04874558', 'briefTitle': 'Ultra-low-dose Chest CT for HHT', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Novel Ultra-low-dose Chest CT Technique to Screen for Pulmonary Arteriovenous Malformations in Pediatric Patients With Hereditary Hemorrhagic Teleangiectasia', 'orgStudyIdInfo': {'id': '21-000324'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low-dose contrast-enhanced chest CT exam', 'description': 'Subjects will undergo a low-dose contrast-enhanced chest CT exam with coverage from the neck base through the lungs to the upper abdomen on a third-generation dual-source CT scanner as part of their routine clinical visit based on current guidelines.', 'interventionNames': ['Diagnostic Test: Ultra-low dose chest CT']}], 'interventions': [{'name': 'Ultra-low dose chest CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'A novel CT technique with a new dose optimization and efficiency technology and automatic kV selection, which greatly reduces the dose of radiation exposure compared to a standard chest CT.', 'armGroupLabels': ['Low-dose contrast-enhanced chest CT exam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Nadir Demirel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nadir Demirel', 'investigatorAffiliation': 'Mayo Clinic'}}}}