Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT03967951
Status:
COMPLETED
Last Update Posted:
2019-12-26
First Post:
2019-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007516', 'term': 'Adenoma, Islet Cell'}], 'ancestors': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-24', 'studyFirstSubmitDate': '2019-05-27', 'studyFirstSubmitQcDate': '2019-05-29', 'lastUpdatePostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interobserver variability in delineating panNENs on CT', 'timeFrame': '6 months', 'description': 'Asses inter-observer variability on CT- scans (with contrast alone)'}], 'secondaryOutcomes': [{'measure': 'Use CT texture analysis to predict, histological characteristics of PanNEN on CT scans', 'timeFrame': '6 months', 'description': 'Evaluate histological characteristics on CT-scans with and without contrast agent in a group of subjects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiomics', 'Pancretic neuroendocrine neoplasms (panNEN)'], 'conditions': ['Pancreatic Neuroendocrine Tumor']}, 'referencesModule': {'references': [{'pmid': '29866335', 'type': 'BACKGROUND', 'citation': "Belli ML, Mori M, Broggi S, Cattaneo GM, Bettinardi V, Dell'Oca I, Fallanca F, Passoni P, Vanoli EG, Calandrino R, Di Muzio N, Picchio M, Fiorino C. Quantifying the robustness of [18F]FDG-PET/CT radiomic features with respect to tumor delineation in head and neck and pancreatic cancer patients. Phys Med. 2018 May;49:105-111. doi: 10.1016/j.ejmp.2018.05.013. Epub 2018 May 23."}, {'pmid': '33523367', 'type': 'DERIVED', 'citation': 'Benedetti G, Mori M, Panzeri MM, Barbera M, Palumbo D, Sini C, Muffatti F, Andreasi V, Steidler S, Doglioni C, Partelli S, Manzoni M, Falconi M, Fiorino C, De Cobelli F. CT-derived radiomic features to discriminate histologic characteristics of pancreatic neuroendocrine tumors. Radiol Med. 2021 Jun;126(6):745-760. doi: 10.1007/s11547-021-01333-z. Epub 2021 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to quantify inter-observer variability in delineating pancreatic neuroendocrine neoplasm (PanNEN) on Computerized Tomography (CT) images and its impact on radiomic features (RF), subsequently to this determination, to use CT texture analysis to predict, histological characteristics of PanNEN on CT scans.', 'detailedDescription': "CT imaging is the most widely used modality for studying radiomic features due to its ability to assess tissue density, shape, texture and size before, during and after therapy. To the best of the investigator's knowledge, the impact of inter-observer delineation variability on the reliability of CT RF for PanNEN patients, including Hounsfield unit (HU) values-, shape-, and texture-based features, has not yet been assessed. One this has been determined, an additional evaluation will be conducted to correlate the morphologically observed images with their histopathological characteristics.\n\nThe ultimate potential objective of this research is to identify and predict characteristics of aggressiveness of PanNEN in CT scans."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Monocentric, retrospective, observational study. Subjects who fulfill the inclusion criteria will be randomly chosen from our Institutional data-base. Thirty patients will be used to evaluate inter-observer variability and forty patients will be used to evaluate histological characteristics on CT-scans with and without contrast agent).\n\nImaged based and clinical variables will be used to construct an overall status of the patient.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years of age\n* pancreatic neuroendocrine neoplasm with intervention and biopsy\n* availability of pre-operatory CT scan with or without IV contrast agent- inInstitution from 2009-2017\n\nExclusion Criteria:\n\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT03967951', 'briefTitle': 'CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms', 'orgStudyIdInfo': {'id': 'panNEN'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CT radiomic feature evaluation', 'type': 'OTHER', 'description': 'Radiomic features will be calculated and extracted from all contrast and non-contrast CT-scans. First order features will be evaluated and high order features will be grouped in parent matrices. Parent matrices of second and third order will be chosen and evaluated.\n\nIn the second part, based on the results of inter-correlation of the operator analysis, the most significant radiomic features will be chosen. Morphological and histopathological features will be evaluated will be.\n\nHistopathology will be performed on a biopsy specimen; percentage of Ki67 and grading will be evaluated.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Deaprtment of Radiology, IRCCS Ospadale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20153', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Francesco De Cobelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology, Head of Clinical and Experimental Radiology', 'investigatorFullName': 'Francesco De Cobelli', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}