Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-06 @ 4:10 AM
Study NCT ID:
NCT04989192
Status:
UNKNOWN
Last Update Posted:
2021-08-18
First Post:
2021-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Efficiency of Modern CT Scanners in Oncologic Scans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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 staging CT scan one of three CT scanners routinely used for this purpose in our department'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-08-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2021-07-23', 'studyFirstSubmitQcDate': '2021-08-03', 'lastUpdatePostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Image Quality', 'timeFrame': '1 year', 'description': 'measured as signal, noise and modulation transfer function equivalent parameters derived from patient scans'}, {'measure': 'Radiation Dose', 'timeFrame': '1 year', 'description': 'measured as x-ray tube parameters such as dose length product (DLP)'}], 'secondaryOutcomes': [{'measure': 'Subjective Image Quality (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', 'CT', 'Computed Tomography', 'Radiation Dose', 'Dose Efficiency'], 'conditions': ['Neoplasms', 'Neoplasm Metastasis', 'Metastatic Cancer']}, 'referencesModule': {'references': [{'pmid': '36897803', 'type': 'DERIVED', 'citation': 'Risch F, Decker JA, Popp D, Sinzinger A, Braun F, Bette S, Jehs B, Haerting M, Wollny C, Scheurig-Muenkler C, Kroencke TJ, Schwarz F. Artifact Reduction From Dental Material in Photon-Counting Detector Computed Tomography Data Sets Based on High-keV Monoenergetic Imaging and Iterative Metal Artifact Reduction Reconstructions-Can We Combine the Best of Two Worlds? Invest Radiol. 2023 Sep 1;58(9):691-696. doi: 10.1097/RLI.0000000000000967.'}]}, 'descriptionModule': {'briefSummary': 'CT-Staging is crucial for therapy planning of patients with malignancies. Dose efficiency and image quality are important parameters for these examinations. Up to now, scientific evidence of dose efficiency of modern CT scanners is mostly derived from retrospective analyses. This prospective study systematically analyzes dose efficiency and image quality of three modern CT scanners by randomization of patients who are scheduled for a CT scan to examine the status of malignancies. After giving informed consent and randomization (1:1:1), the CT scan will be performed at one of the modern CT scanners available at our department. This will allow a systematic allocation to the different scanners.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* clinical suspicion of a malignancy or known / confirmed malignancy AND\n* indication for contrast-enhanced CT of the body confirmed by board-certified radiologist ('justifying indication' according to German/European radiation protection law) AND\n* patient (is able to give informed consent and) has given informed consent.\n\nExclusion Criteria:\n\n* age \\< 18 years\n* known or suspected pregnancy\n* contraindications for contrast agent (renal failure, allergy, hyperthyroidism)"}, 'identificationModule': {'nctId': 'NCT04989192', 'briefTitle': 'Dose Efficiency of Modern CT Scanners in Oncologic Scans', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Augsburg'}, 'officialTitle': 'On Dose Efficiency of Modern CT-Scanners in the Staging of Malignancies - a Prospective Randomized Study', 'orgStudyIdInfo': {'id': '21-0280'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CT scanner 1', 'description': 'Patients will undergo imaging on scanner 1.', 'interventionNames': ['Diagnostic Test: Scan at CT scanner 1']}, {'type': 'OTHER', 'label': 'CT scanner 2', 'description': 'Patients will undergo imaging on scanner 2.', 'interventionNames': ['Diagnostic Test: Scan at CT scanner 2']}, {'type': 'OTHER', 'label': 'CT scanner 3', 'description': 'Patients will undergo imaging on scanner 3.', 'interventionNames': ['Diagnostic Test: Scan at CT scanner 3']}], 'interventions': [{'name': 'Scan at CT scanner 1', 'type': 'DIAGNOSTIC_TEST', '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 among all three arms.', 'armGroupLabels': ['CT scanner 1']}, {'name': 'Scan at CT scanner 2', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will undergo imaging on a modern 128 slice CT-scanner without spectral imaging capabilities. A standard acquisition protocol will be used. Contrast material protocol and scan ranges are similar among all three arms.', 'armGroupLabels': ['CT scanner 2']}, {'name': 'Scan at CT scanner 3', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will undergo imaging on a modern 20 slice CT-scanner without spectral imaging capabilities. A standard acquisition protocol will be used. Contrast material protocol and scan ranges are similar among all three arms.', 'armGroupLabels': ['CT scanner 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86156', 'city': 'Augsburg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Florian Schwarz, MD', 'role': 'CONTACT', 'email': 'radiologie-studien@uk-augsburg.de', 'phone': '+498214002441'}], 'facility': 'University Hospital Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}], 'centralContacts': [{'name': 'Florian Schwarz, MD', 'role': 'CONTACT', 'email': 'radiologie-studien@uk-augsburg.de', 'phone': '+498214002441'}], 'overallOfficials': [{'name': 'Florian Schwarz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Augsburg'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], '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'}}}}