Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT03430635
Status:
COMPLETED
Last Update Posted:
2018-02-13
First Post:
2018-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Choline PET/CT in Predicting Survival in Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006498', 'term': 'Hepatectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2018-01-20', 'studyFirstSubmitQcDate': '2018-02-06', 'lastUpdatePostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of PET/CT parameters that can be predictors of survival', 'timeFrame': 'From date of surgery until the date of first documented progression or date of death from any cause, whichever came first assessed up to 72 months', 'description': 'Identification of specific PET/CT parameters that can be used as independent predictors of overall and/or disease-free survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '28723716', 'type': 'BACKGROUND', 'citation': 'Lanza E, Donadon M, Felisaz P, Mimmo A, Chiti A, Torzilli G, Balzarini L, Lopci E. Refining the management of patients with hepatocellular carcinoma integrating 11C-choline PET/CT scan into the multidisciplinary team discussion. Nucl Med Commun. 2017 Oct;38(10):826-836. doi: 10.1097/MNM.0000000000000719.'}, {'pmid': '25962590', 'type': 'BACKGROUND', 'citation': 'Lopci E, Torzilli G, Poretti D, de Neto LJ, Donadon M, Rimassa L, Lanza E, Sabongi JG, Ceriani R, Personeni N, Palmisano A, Pedicini V, Comito T, Scorsetti M, Chiti A. Diagnostic accuracy of (1)(1)C-choline PET/CT in comparison with CT and/or MRI in patients with hepatocellular carcinoma. Eur J Nucl Med Mol Imaging. 2015 Aug;42(9):1399-407. doi: 10.1007/s00259-015-3079-5. Epub 2015 May 12.'}]}, 'descriptionModule': {'briefSummary': '¹¹C-choline positron emission tomography/computed tomography (PET/CT) has been used in patients with some types of solid cancers, but few data are available in patients undergoing hepatectomy for hepatocellular carcinoma (HCC). The aim of this study was to analyze the prognostic value of metabolic imaging data by using ¹¹C-choline PET/CT in patients with HCC before hepatectomy.', 'detailedDescription': 'Our prospectively maintained liver unit database was queried for patients with HCC preoperatively staged with ¹¹C-choline PET/CT. This metabolic imaging modality was performed in addition to standard abdominal CT or magnetic resonance imaging. Several PET/CT parameters were recorded and analyzed. Univariate and multivariate analyses were performed to identify whether those PET/CT parameters could be predictors of overall survival (OS) and disease-free survival (DFS) of HCC patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by HCC candidate to surgical resection that were preoperatively staged with ¹¹C-choline PET/CT.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient with HCC candidate to surgical resection preoperatively staged with ¹¹C-choline PET/CT\n\nExclusion Criteria:\n\n* R2 resection;\n* Intraoperative use of RFA/MWI\n* Postoperative death (90-days)'}, 'identificationModule': {'nctId': 'NCT03430635', 'briefTitle': 'Role of Choline PET/CT in Predicting Survival in Patients With Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Humanitas Clinical and Research Center'}, 'officialTitle': 'What is the Prognostic Value of ¹¹C-choline PET/CT in Patients Undergoing Hepatectomy for Hepatocellular Carcinoma?', 'orgStudyIdInfo': {'id': 'CholinePETforHCC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hepatectomy', 'type': 'PROCEDURE', 'otherNames': ['Hepatic resection; liver resection.'], 'description': 'Surgery of the liver: removal of a given part of the liver affected by hepatocellular carcinoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanitas Clinical and Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Matteo Donadon', 'investigatorAffiliation': 'Humanitas Clinical and Research Center'}}}}