Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-31 @ 2:22 AM
Study NCT ID:
NCT06305156
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2024-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocol Optimization in CT for the Quantification of BMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone mineral density CT', 'timeFrame': 'Immediately after CT scan of the participant.', 'description': 'Bone mineral density derived from CT Scan'}, {'measure': 'Bone mineral density Dual-energy x-ray absorptiometry (DXA)', 'timeFrame': 'Immediately after DXA scan of the participant.', 'description': 'Bone mineral density derived from DXA Scan'}], 'secondaryOutcomes': [{'measure': 'Correlation between age and bone mineral density', 'timeFrame': '1 year', 'description': 'Correlation analysis by means of linear regression and pearson correlation between age (in years) and bone mineral density'}, {'measure': 'Correlation between sex and bone mineral density', 'timeFrame': '1 year', 'description': 'Correlation analysis by means of linear regression and pearson correlation between sex (male/female) and bone mineral density'}, {'measure': 'Correlation between height and bone mineral density', 'timeFrame': '1 year', 'description': 'Correlation analysis by means of linear regression and pearson correlation between height (in cm) and bone mineral density'}, {'measure': 'Correlation between weight and bone mineral density', 'timeFrame': '1 year', 'description': 'Correlation analysis by means of linear regression and pearson correlation between weight and bone mineral density'}, {'measure': 'Correlation between body mass index (BMI) and bone mineral density', 'timeFrame': '1 year', 'description': 'Correlation analysis by means of linear regression and pearson correlation between body mass index (BMI, in kg/m\\^2) and bone mineral density'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis, Osteopenia', 'Bone Loss']}, 'descriptionModule': {'briefSummary': 'Bone mineral density is an important measurement to detect osteoporosis.\n\nThe goal of this clinical trial is to compare bone mineral density measurements in CT examinations and DXA scans. The main question it aims to answer is:\n\n* How good is the measurement of bone mineral density in the new photon-counting CT in comparison to DXA\n* How can we optimize the CT scan for bone mineral density\n\nParticipants will undergo:\n\n* Clinically indicated CT scan on day of inclusion\n* Study related DXA scan on a separate appointment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent signed by the subject\n* Referral to a regular clinically indicated CT examination covering the lumbar area (e.g., Abdomen, Thorax + Abdomen, Neck + Thorax +Abdomen)\n* Informed written and oral consent (interpreter present in case of foreign language patients)\n* No contraindication to the clinically indicated CT examination\n\nExclusion Criteria:\n\n* Patients \\< 18 years\n* Pregnant women\n* Vulnerable subjects\n* Contraindications to the clinically indicated CT scan\n* Multiple Myeloma\n* Diffuse bone metastasis\n* Fixateur interne in the lumbar spine\n* Kyphoplasty in the lumbar spine\n* Enterally administrated contrast agent\n* Obtaining informed consent is not possible\n* Withdrawal of consent orally or in writing\n* Inability to follow the procedures of the investigation, e.g., due to language problems, psychological disorders, dementia, etc. of the subject\n* Immobility (patients confined to a wheelchair or to bed)'}, 'identificationModule': {'nctId': 'NCT06305156', 'briefTitle': 'Protocol Optimization in CT for the Quantification of BMD', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Protocol-optimization in Computed Tomography for the Quantification of Bone Mineral Density (BMD)', 'orgStudyIdInfo': {'id': 'CT_BMD_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Bone mineral density CT vs DXA', 'description': 'Single arm study, all participants receive CT and DXA.', 'interventionNames': ['Diagnostic Test: Bone Mineral Density quantification']}], 'interventions': [{'name': 'Bone Mineral Density quantification', 'type': 'DIAGNOSTIC_TEST', 'description': 'In the first visit, participants receive clinically indicated CT scan, where bone mineral density will be derived.\n\nIn a second, study related visit, participants will receive a DXA scan for bone mineral quantifications.', 'armGroupLabels': ['Bone mineral density CT vs DXA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Hatem Alkadhi, MD, MPH', 'role': 'CONTACT', 'email': 'hatem.alkadhi@usz.ch', 'phone': '+41 44 255 36 62'}], 'facility': 'Diagnostic and Interventional Radiology, University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Hatem Alkadhi, MD, MPH', 'role': 'CONTACT', 'email': 'hatem.alkadhi@usz.ch', 'phone': '+41 44 255 36 62'}], 'overallOfficials': [{'name': 'Hatem Alkadhi, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diagnostic and Interventional Radiology, University Hospital Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hatem Alkadhi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Attending Physician, Vice Director of the Institute, Institute for Diagnostic and Interventional Radiology', 'investigatorFullName': 'Hatem Alkadhi', 'investigatorAffiliation': 'University of Zurich'}}}}