Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:30 PM
Study NCT ID:
NCT07351669
Status:
RECRUITING
Last Update Posted:
2026-03-19
First Post:
2025-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Prospective Study on the Performance of Spectral CT for Evaluating Treatment Response After TACE in Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2025-12-29', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of spectral CT in identifying nonviable HCC lesions.', 'timeFrame': 'From enrollment to the completion of the 1-year follow-up', 'description': 'Two or more investigators independently evaluated the multiparametric spectral CT images of the patients using the mRECIST criteria. The imaging assessment results were recorded as CR, PR, PD, or SD. First, the agreement between spectral CT-based assessments and those obtained from conventional clinical CT was evaluated. Subsequently, the spectral CT imaging results were compared with the reference standard to assess the diagnostic accuracy of spectral CT.'}, {'measure': 'Diagnostic Performance of Spectral CT for Residual Viable Hepatocellular Carcinoma After TACE.', 'timeFrame': 'From enrollment to the completion of the 1-year follow-up.', 'description': 'Imaging Assessment Criteria:\n\nFor target lesions, imaging evaluation was performed using the mRECIST and LI-RADS TRA v2024 criteria, with histopathological findings serving as the reference standard.\n\nImaging Assessment Procedure:\n\nTwo or more investigators independently and blindly reviewed the multiparametric spectral CT images of the patients. Lesions were assessed using the mRECIST criteria. The imaging assessment results were recorded as CR, PR, PD, or SD. The imaging findings were compared with the pathological reference standard to assess the diagnostic performance of spectral CT.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HCC - Hepatocellular Carcinoma', 'TACE(Transcatheter Arterial Chemoembolization)', 'CT']}, 'descriptionModule': {'briefSummary': 'By comparing the diagnostic accuracy of spectral CT and conventional CT in evaluating treatment response efficacy after TACE, this study aims to investigate the diagnostic performance of spectral CT in assessing treatment response following TACE for hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients recruited from six comprehensive medical centers nationwide', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria01:\n\n1. Voluntary participation and ability to sign informed consent (post-TACE);\n2. Age between 18 and 75 years;\n3. Diagnosed as HCC based on pathology or clinical criteria, with a BCLC stage of A or B;\n4. Patients undergo contrast-enhanced spectral CT 4-8 weeks after treatment and are assessed as complete response on conventional CT images;\n5. Patients are scheduled to undergo surgical resection within one month, or DSA hepatic arteriography or contrast-enhanced MRI within one week. If none of these were planned, the patients were scheduled for imaging follow-up (CT or MRI) every 3 months (±15 days) for at least one year.\n\nInclusion Criteria02:\n\n1. Voluntary participation and ability to sign informed consent (post-TACE, cTACE or DEB-TACE);\n2. Age between 18 and 75 years;\n3. Diagnosed as HCC based on pathology or clinical criteria, with a BCLC stage of A or B;\n4. Patients plan to undergo liver tumor resection following TACE downstaging therapy;\n5. Contrast-enhanced spectral CT was performed within 7 days before liver resection, after completion of TACE down-staging treatment.\n\nExclusion Criteria:\n\n1. Contraindications to contrast-enhanced CT or contrast-enhanced MRI;\n2. Presence of extrahepatic malignancies;\n3. History of radiotherapy;\n4. Poor image quality or incomplete clinical/imaging data; Withdrawal from the study midway.'}, 'identificationModule': {'nctId': 'NCT07351669', 'briefTitle': 'A Multicenter Prospective Study on the Performance of Spectral CT for Evaluating Treatment Response After TACE in Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'The Performance of Spectral CT in Evaluating Treatment Response After Transarterial Chemoembolization for Hepatocellular Carcinoma: The SpecTRAIL Study', 'orgStudyIdInfo': {'id': '2025ZDSYLL494-P01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuhang Zhang', 'role': 'CONTACT', 'email': 'shuhangzhang@outlook.com', 'phone': '86 13852914095'}], 'facility': 'Zhongda Hospital Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Shuhang Zhang', 'role': 'CONTACT', 'email': 'shuhangzhang@outlook.com', 'phone': '86 13852914095'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Radiology', 'investigatorFullName': 'Yuan-Cheng Wang', 'investigatorAffiliation': 'Zhongda Hospital'}}}}