Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-25 @ 4:45 AM
Study NCT ID:
NCT04027556
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2019-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-contrast Dose Liver CT Using Lean Body Weight Low Monoenergetic Images and Deep Learning-based Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-27', 'studyFirstSubmitDate': '2019-07-18', 'studyFirstSubmitQcDate': '2019-07-19', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HCC conspicuity', 'timeFrame': '6 months after complete enrollment', 'description': 'qualitative scoring for focal lesion depiction on four-point scale (1: worst, 4: excellent, representative value is average score)'}], 'secondaryOutcomes': [{'measure': 'Image noise', 'timeFrame': '12 months after complete enrollment', 'description': 'qualitative scoring for image noise on four-point scale (1: worst, 4: excellent, representative value is average score)'}, {'measure': 'Image contrast', 'timeFrame': '12 months after complete enrollment', 'description': 'qualitative scoring for image contrast on four-point scale (1: worst, 4: excellent, representative value is average score)'}, {'measure': 'Overall image quality', 'timeFrame': '6 months after complete enrollment', 'description': 'qualitative scoring for image quality on four-point scale (1: worst, 4: excellent, representative value is average score)'}, {'measure': 'Lesion detection', 'timeFrame': '12 months after complete enrollment', 'description': 'assessment of focal liver lesion (HCC) on CT according to Liver Imaging Reporting and Data System (LI-RADS)'}, {'measure': 'Hounsfield unit', 'timeFrame': '3 months after complete enrollment', 'description': 'measurement of hounsfield unit in aorta, portal vein, liver parenchyma, and paraspinal muscles'}, {'measure': 'Contrast media dose', 'timeFrame': '3 months after complete enrollment', 'description': 'administered contrast media dose in each group'}, {'measure': 'Radiation dose', 'timeFrame': '3 months after complete enrollment', 'description': 'measured radiation dose in each group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carcinoma, Hepatocellular', 'Body Weight']}, 'descriptionModule': {'briefSummary': 'This study aims to assess whether the acceptable image quality is achievable using low monoenergetic imaging of dual-energy CT with deep learning-based denoising, and low contrast media dose calculated based on lean body weight for the detection of hepatocellular carcinoma.', 'detailedDescription': 'The use of iodinated contrast media in CT is associated with an immediate hypersensitivity reaction in a dose-dependent manner. Therefore, it is important to reduce the contrast dose for CT exams in patients who are required repeated CT examinations, including patients with hepatocellular carcinoma (HCC). Low monoenergetic images of dual-energy CT can provide higher iodine contrast than conventional images, thus enabling reduction of contrast media. The high image noise in low monoenergetic images may be improved by using model-based IR techniques and deep learning-based denoising (DLD) algorithms. Besides, lean body weight (LBW)-based contrast dose determination can be another option to reduce contrast media dose compared with total body weight-based dose determination since the volumes of blood and liver are not strictly proportional to total body weight. Therefore, we surmised that 50 keV images reconstructed with DLD algorithms with reducing iodine load by 30% based on LBW could produce the comparable image quality and lesion conspicuity compared with standard iodine-dose 120kVp images.\n\nIn this single-center prospective, randomized clinical trial, we aimed to investigate the effectiveness of low-contrast dose CT using 50 keV and DLD technique compared with the standard contrast-dose protocol using model-based IR in patients at high risk of HCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High risk group for developing HCC\n* Scheduled contrast-enhanced CT for HCC diagnosis or surveillance\n\nExclusion Criteria:\n\n* not a high risk group for developing HCC\n* body mass index is equal to or larger than 30 kg/m\\^2\n* suspected HCC \\> 5cm in diameter\n* received locoregional treatment or surgery for HCC within 3 months\n* congestive hepatopathy\n* no venous access on forearm\n* anticipated beam hardening artifact due to prosthesis\n* relative/absolute contraindication of contrast-enhanced CT'}, 'identificationModule': {'nctId': 'NCT04027556', 'briefTitle': 'Low-contrast Dose Liver CT Using Lean Body Weight Low Monoenergetic Images and Deep Learning-based Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Low-contrast Dose Liver CT Using Lean Body Weight, Low Monoenergetic Images and Deep Learning-based Reconstruction for Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'SNUH-2019-0344'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '50 keV DLD images of the LBW-based low-dose group', 'description': 'Low CT contrast media dose calculated based on lean body weight and low monoenergetic images of dual-energy CT with deep learning-based denoising', 'interventionNames': ['Other: low dose CT contrast media - lean body weight']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ADMIRE images of the standard-contrast dose group', 'description': 'Standard CT contrast media dose calculated based on total body weight and conventional images with full model-based iterative reconstruction', 'interventionNames': ['Other: Standard dose CT contrast media']}], 'interventions': [{'name': 'low dose CT contrast media - lean body weight', 'type': 'OTHER', 'description': 'CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 450mgI/kg based on lean body weight.', 'armGroupLabels': ['50 keV DLD images of the LBW-based low-dose group']}, {'name': 'Standard dose CT contrast media', 'type': 'OTHER', 'description': 'CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 560mgI/kg based on total body weight.', 'armGroupLabels': ['ADMIRE images of the standard-contrast dose group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jeong Min Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Siemens Corporation, Corporate Technology', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong Min Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}