Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT04996693
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2021-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
On Dose Efficiency of Modern CT-scanners in Chest Scans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'no masking required'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization of patients referred for a CT scan of the thorax on one of three CT scanners routinely used for this purpose in our department'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 958}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2021-07-23', 'studyFirstSubmitQcDate': '2021-07-30', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parameters of Objective Image Quality', 'timeFrame': '1 year', 'description': 'Measured as signal, image noise and modulation transfer function equivalent parameters'}, {'measure': 'Parameters of Radiation Dose', 'timeFrame': '1 year', 'description': 'measured as x-ray tube parameters such as dose length product (DLP)'}], 'secondaryOutcomes': [{'measure': 'Subjective Image Quality Evaluation (entire cohort and for individual disease groups)', 'timeFrame': '1 year', 'description': 'measured by blinded evaluation by radiologists'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spectral CT', 'Computed Tomography', 'Dose efficiency'], 'conditions': ['Pneumonia', 'Lung Cancer', 'Pulmonary Embolism', 'Pulmonary Disease', 'Aortic Stenosis']}, 'descriptionModule': {'briefSummary': 'CT scans of the chest / thorax are of great importance both in the initial diagnosis and in the follow-up of pulmonary or thoracic diseases. As an example, CT angiography of the pulmonary arteries (CTPA) is worldwide considered to be gold standard test in patients with a suspicion for pulmonary embolism.\n\nThe aim of this study is to measure and compare dose efficiency of modern CT scanners for unenhanced and contrast-enhanced scan protocols of the chest/thorax. Patients who are referred for a CT of the chest/thorax will be randomly assigned to one of the three CT scanners currently in use at our institution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patient is referred for an unenhanced CT OR contrast-enhanced CT of the chest/thorax confirmed by a board-certified radiologist ('justifying indication' according to German/European radiation protection law) AND\n* patient is at least 18 years of age AND\n* patient (is able to give informed consent and) has given informed consent.\n\nExclusion Criteria:\n\n* high degree of medical urgency (i.e. patient cannot be consented for iv contrast according to routine procedures)\n* known or suspected pregnancy, or lactating . contraindications for contrast agent (renal failure, allergy, hyperthyroidism)"}, 'identificationModule': {'nctId': 'NCT04996693', 'briefTitle': 'On Dose Efficiency of Modern CT-scanners in Chest Scans', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Augsburg'}, 'officialTitle': 'On Dose Efficiency of Modern CT-scanners in Chest Scans- a Prospective, Randomized Study', 'orgStudyIdInfo': {'id': '21-0368'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Scanner 1', 'description': 'Imaging performed on scanner 1: Photon-Counting Detector CT', 'interventionNames': ['Diagnostic Test: Imaging on Scanner with Spectral Imaging Capabilities']}, {'type': 'OTHER', 'label': 'Scanner 2', 'description': 'Imaging performed on scanner 2: Energy-Integrating Detector CT (128-slice)', 'interventionNames': ['Diagnostic Test: CT Scan using an Energy-Integrating Detector CT (128 slice MDCT)']}, {'type': 'OTHER', 'label': 'Scanner 3', 'description': 'Imaging performed on scanner 3: Energy-Integrating Detector CT (20-slice)', 'interventionNames': ['Diagnostic Test: CT Scan using an Energy-Integrating Detector CT (20-slice MDCT)']}], 'interventions': [{'name': 'Imaging on Scanner with Spectral Imaging Capabilities', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['CT Scan using a Photon-Counting Detector CT: Naeotom Alpha (Siemens Healthineers)'], 'description': 'Patients will undergo imaging on a modern CT scanner with spectral imaging capabilities. A dose neutral spectral acquisition mode will routinely be used. Contrast material protocol and scan ranges are similar in all three arms.', 'armGroupLabels': ['Scanner 1']}, {'name': 'CT Scan using an Energy-Integrating Detector CT (128 slice MDCT)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will undergo imaging on a modern 128-slice CT scanner (Siemens Healthineers) with energy-integrating detector and without spectral acquisition mode. Contrast material protocol and scan ranges are similar in all three arms.', 'armGroupLabels': ['Scanner 2']}, {'name': 'CT Scan using an Energy-Integrating Detector CT (20-slice MDCT)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will undergo imaging on a modern 20-slice CT scanner (Siemens Healthineers) with energy-integrating detector and without spectral acquisition mode. Contrast material protocol and scan ranges are similar in all three arms.', 'armGroupLabels': ['Scanner 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86156', 'city': 'Augsburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'University Hospital Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}], 'overallOfficials': [{'name': 'Florian Schwarz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaetsklinikum Augsburg'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Requests for sharing individual participant data will be considered at the time of publication of the first manuscript containing result data.', 'ipdSharing': 'YES', 'description': 'We plan to share individual participant data upon request (pending final approval by the data protection officer).', 'accessCriteria': 'We plan to share data on request at this point in time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Augsburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}