Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-29 @ 11:31 AM
Study NCT ID:
NCT06168357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Abbreviated MRI in Follow-up of Hepatocellular Carcinoma .
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between tumor enhancement in arterial phase expressed as Hounsfield unit number and ADC value.', 'timeFrame': 'Baseline', 'description': 'correlation between tumor enhancement in arterial phase expressed as Hounsfield unit number and ADC value.'}]}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '31907050', 'type': 'RESULT', 'citation': 'Liu Z, Fan JM, He C, Li ZF, Xu YS, Li Z, Liu HF, Lei JQ. Utility of diffusion weighted imaging with the quantitative apparent diffusion coefficient in diagnosing residual or recurrent hepatocellular carcinoma after transarterial chemoembolization: a meta-analysis. Cancer Imaging. 2020 Jan 6;20(1):3. doi: 10.1186/s40644-019-0282-9.'}, {'pmid': '29628281', 'type': 'RESULT', 'citation': 'European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.'}, {'pmid': '33330098', 'type': 'RESULT', 'citation': 'Sung PS, Choi MH, Yang H, Lee SK, Chun HJ, Jang JW, Choi JY, Yoon SK, Choi JI, Lee YJ, Bae SH. Diffusion-Weighted Magnetic Resonance Imaging in Hepatocellular Carcinoma as a Predictor of a Response to Cisplatin-Based Hepatic Arterial Infusion Chemotherapy. Front Oncol. 2020 Nov 19;10:600233. doi: 10.3389/fonc.2020.600233. eCollection 2020.'}, {'pmid': '27471573', 'type': 'RESULT', 'citation': 'Gluskin JS, Chegai F, Monti S, Squillaci E, Mannelli L. Hepatocellular Carcinoma and Diffusion-Weighted MRI: Detection and Evaluation of Treatment Response. J Cancer. 2016 Jul 13;7(11):1565-70. doi: 10.7150/jca.14582. eCollection 2016.'}, {'pmid': '28937853', 'type': 'RESULT', 'citation': 'Wang WT, Yang L, Yang ZX, Hu XX, Ding Y, Yan X, Fu CX, Grimm R, Zeng MS, Rao SX. Assessment of Microvascular Invasion of Hepatocellular Carcinoma with Diffusion Kurtosis Imaging. Radiology. 2018 Feb;286(2):571-580. doi: 10.1148/radiol.2017170515. Epub 2017 Sep 22.'}, {'pmid': '26854170', 'type': 'RESULT', 'citation': 'Ludwig JM, Camacho JC, Kokabi N, Xing M, Kim HS. The Role of Diffusion-Weighted Imaging (DWI) in Locoregional Therapy Outcome Prediction and Response Assessment for Hepatocellular Carcinoma (HCC): The New Era of Functional Imaging Biomarkers. Diagnostics (Basel). 2015 Nov 30;5(4):546-63. doi: 10.3390/diagnostics5040546.'}, {'pmid': '33708636', 'type': 'RESULT', 'citation': 'Surov A, Pech M, Omari J, Fischbach F, Damm R, Fischbach K, Powerski M, Relja B, Wienke A. Diffusion-Weighted Imaging Reflects Tumor Grading and Microvascular Invasion in Hepatocellular Carcinoma. Liver Cancer. 2021 Feb;10(1):10-24. doi: 10.1159/000511384. Epub 2021 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'Role of ADC value and DWI in abbreviated MRI compared to post-contrast CT in follow-up of HCC after TACE.', 'detailedDescription': 'Hepatocellular carcinoma (HCC) is the 5th most common cancer in the world and the most common in Egypt .\n\nTrans-arterial chemoembolization (TACE) is the treatment recommended for unresectable HCC according to Barcelona clinic liver cancer staging and is widely used .\n\nHCC is nourished only by the hepatic artery, so TACE causes ischemia and coagulative necrosis. However; viable neoplastic tissue residual may be seen after TACE. Assessment of post-TACE tumor response is important in determining treatment success and in guiding future therapy .\n\nMany studies have assessed the diagnostic performance of multiphasic contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI) in diagnosis of HCC with noted higher sensitivity of MRI compared to CT. CT or MRI are recommended for assessment of response after treatment as well .\n\nDiffusion-weighted imaging (DWI) and apparent diffusion coefficient (ADC) are functional MRI techniques that detect signal changes in tissues due to water proton motion. The intact membranes of viable tumor cells restrict water diffusion, whereas necrotic tumor cells with disrupted cell membranes exhibit increased water diffusion and which differentiate the biological activity of HCC'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent TACE for unresectable HCC with patent portal vein based on Doppler, no ascites, and satisfactory liver function.\n\nAge between 20-year old and 85-year old.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who underwent TACE for unresectable HCC with patent portal vein based on Doppler, no ascites, and satisfactory liver function.\n\nAge between 20-year old and 85-year old\n\nExclusion Criteria:\n\n* Estimated GFR less than 60 Previous history of severe allergic reaction to the iodinated contrast agent Patients with claustrophobia who can't undergo MR examination. Patients having cochlear implants or cardiac pacemaker"}, 'identificationModule': {'nctId': 'NCT06168357', 'briefTitle': 'Role of Abbreviated MRI in Follow-up of Hepatocellular Carcinoma .', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Abbreviated MRI in Follow-up of Hepatocellular Carcinoma Following Locoregional Treatment.', 'orgStudyIdInfo': {'id': 'Role of MRI in HCC'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nour Mokhles Farah, Resident doctor', 'role': 'CONTACT', 'email': 'Nmokhles492@gmail.com', 'phone': '01212872901'}, {'name': 'Mostafa Ahmed Sayed, Lecturer', 'role': 'CONTACT', 'email': 'most.rad@aun.edu.eg', 'phone': '01092300511'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Nour Mokhles Farah', 'investigatorAffiliation': 'Assiut University'}}}}