Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04722120
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2016-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Contrast Agent and Radiation Dose Protocol for Liver CT in Patients With HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003226', 'term': 'Congresses as Topic'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D003287', 'term': 'Contrast Media'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D064907', 'term': 'Diagnostic Uses of Chemicals'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Participants, investigators, and outcome assessors were all masked to the allocation'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-29', 'studyFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2021-01-21', 'lastUpdatePostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rate of solid focal lesion in liver', 'timeFrame': "12 months after last patient's image work up", 'description': 'diagnostic performance'}, {'measure': 'Quantitative image quality analysis', 'timeFrame': 'Immediate after study enrollement', 'description': 'Contrast-to-Noise'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CT'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the image quality and clinical feasibility of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.', 'detailedDescription': 'The purpose of this study is to investigate the image quality (CNR, subjective inage quality, vessel and lesion conspicuity) and clinical feasibility (rate of lesion detection) of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver cirrhosis\n* Tumor marker (aFP, PIVKA) elevation\n* Nodular lesion on USG\n* Received RFA for HCC\n\nExclusion Criteria:\n\n* hypersensitivity at iodine\n* GFR under 30\n* BMI over 30\n* Nursing or pregnant women\n* enrolled the other study'}, 'identificationModule': {'nctId': 'NCT04722120', 'briefTitle': 'Low Contrast Agent and Radiation Dose Protocol for Liver CT in Patients With HCC', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Low Contrast Agent and Radiation Dose Protocol Liver CT With Deep-learning-based Contrast Boosting Model in Patients at High Risk for HCC: Prospective, Randomized, Single Blinded - Preliminary Study', 'orgStudyIdInfo': {'id': 'SNUH-2016-2272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional liver CT', 'description': 'Underwent conventional liver CT on HCC high-risk patient', 'interventionNames': ['Radiation: Conventional CT (radiation)', 'Drug: Conventional CT (contrast agent)']}, {'type': 'EXPERIMENTAL', 'label': 'Double low dose CT', 'description': 'Underwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient', 'interventionNames': ['Radiation: Low radiation dose CT', 'Drug: Low contrast dose CT', 'Other: Deep-learning based contrast boosting algorithms']}], 'interventions': [{'name': 'Low radiation dose CT', 'type': 'RADIATION', 'description': 'Underwent liver CT with 30% lower radiation dose', 'armGroupLabels': ['Double low dose CT']}, {'name': 'Conventional CT (radiation)', 'type': 'RADIATION', 'description': 'Underwent liver CT without change of radiation.', 'armGroupLabels': ['Conventional liver CT']}, {'name': 'Low contrast dose CT', 'type': 'DRUG', 'otherNames': ['Low contrast medium dosage'], 'description': 'Underwent liver CT 20% lower dose contrast media.', 'armGroupLabels': ['Double low dose CT']}, {'name': 'Conventional CT (contrast agent)', 'type': 'DRUG', 'otherNames': ['Standard contrast medium dosage'], 'description': 'Underwent liver CT without change of contrast media doses.', 'armGroupLabels': ['Conventional liver CT']}, {'name': 'Deep-learning based contrast boosting algorithms', 'type': 'OTHER', 'description': 'Applied deep-learning based contrast boosting algorithms on acquired CT images', 'armGroupLabels': ['Double low dose CT']}]}, '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'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong Min Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}