Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-04 @ 12:09 AM
Study NCT ID:
NCT06853457
Status:
COMPLETED
Last Update Posted:
2025-03-03
First Post:
2025-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Transfer Learning Radiomics Model for Predicting Response to Initial Transarterial Embolization in Patients with Gastroenteropancreatic Neuroendocrine Tumor Liver Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2025-02-23', 'studyFirstSubmitQcDate': '2025-02-28', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of TAE', 'timeFrame': 'Within one month prior and 4-6 weeks following the initial TAE.', 'description': 'Complete multiphase contrast-enhanced CT images were collected preoperatively and postoperatively. The efficacy of TAE was assessed based on RECIST 1.1 criteria. Patients were classified as objective responders (those achieving complete response \\[CR\\] or partial response \\[PR\\]) or non-responders (those with stable disease \\[SD\\] or progressive disease \\[PD\\]) through evaluation of target lesions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuroendocrine Tumors, NET']}, 'descriptionModule': {'briefSummary': 'To develop and validate a CT-based transfer learning radiomics model for predicting response to initial TAE in GEP-NETLM patients and compare its performance with traditional radiomics and clinical models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study retrospectively included gastroenteropancreatic neuroendocrine tumors liver metastasis patients who receive initial transarterial embolization from January 2014 to September 2022 at The First Affiliated Hospital of Sun Yat-sen University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (a) Clinical diagnosed as gastroenteropancreatic neuroendocrine tumor liver metastases; (b) Received initial transarterial embolization therapy; (c) Underwent multi-phase ceCT scans pre-TAE (≤1 month) and post-TAE (4-6 weeks).\n\nExclusion Criteria:\n\n* (a) Neuroendocrine carcinoma (NEC) or other malignancies. (b) Received other liver metastasis treatments. (c) Lack of Multi-phase ceCT scans records. (d) CT images with artifacts or no visible lesions.'}, 'identificationModule': {'nctId': 'NCT06853457', 'briefTitle': 'A Transfer Learning Radiomics Model for Predicting Response to Initial Transarterial Embolization in Patients with Gastroenteropancreatic Neuroendocrine Tumor Liver Metastases', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'A Transfer Learning Radiomics Model for Predicting Response to Initial Transarterial Embolization in Patients with Gastroenteropancreatic Neuroendocrine Tumor Liver Metastases: from Lesion-targeted to Patient-targeted Prediction', 'orgStudyIdInfo': {'id': 'IIT-2023-983'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'training set', 'description': 'The training set consisted of patients from January 2014 to December 2020.'}, {'label': 'testing set', 'description': 'the testing set included patients from January 2021 to September 2022.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiao-Yu Yin', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}