Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT04360993
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2020-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of PET/MRI in Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-24', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-22', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Apparent diffusion coefficient value between benign and malignant lesions', 'timeFrame': 'Baseline', 'description': 'Apparent diffusion coefficient (ADC) was measured from benign and malignant lymph nodes by drawing region of interest (ROI) on the most homogeneous and most solid part in the target lymph node. Higher ADC value in Benign lymph node means that there are more water molecules movement inside the lymph node, more water molecules movement resulting in higher Apparent diffusion coefficient value. in malignant nodes and due to more tumor tissue, the result is to have lower water molecules motion so, lower ADC value.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer', 'Benign Neoplasm', 'Malignant Neoplasm']}, 'referencesModule': {'references': [{'pmid': '33640578', 'type': 'DERIVED', 'citation': 'Freihat O, Toth Z, Pinter T, Kedves A, Sipos D, Cselik Z, Lippai N, Repa I, Kovacs A. Pre-treatment PET/MRI based FDG and DWI imaging parameters for predicting HPV status and tumor response to chemoradiotherapy in primary oropharyngeal squamous cell carcinoma (OPSCC). Oral Oncol. 2021 May;116:105239. doi: 10.1016/j.oraloncology.2021.105239. Epub 2021 Feb 25.'}, {'pmid': '32771060', 'type': 'DERIVED', 'citation': 'Freihat O, Pinter T, Kedves A, Sipos D, Cselik Z, Repa I, Kovacs A. Diffusion-Weighted Imaging (DWI) derived from PET/MRI for lymph node assessment in patients with Head and Neck Squamous Cell Carcinoma (HNSCC). Cancer Imaging. 2020 Aug 8;20(1):56. doi: 10.1186/s40644-020-00334-x.'}]}, 'descriptionModule': {'briefSummary': 'Study aim was to investigate the diagnostic role of Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) in head and neck cancer.', 'detailedDescription': 'This study was assessed the role of Diffusion weighted imaging (DWI) in discriminating between benign and malignant lesions in Head and neck cancer as well as studying the relationship between glucose metabolism (18F-FDG) and Apparent diffusion coefficient (ADC) for better tumor assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '41 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population were patients who have been diagnosed with head and neck cancer.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Proved Head and neck cancer\n* Underwent PET/CT and PET/MRI\n* Lymph nodes due to primary Head and neck cancer.\n\nFor healthy subject:\n\n* No previous history of malignancy.\n* no inflammation or infection in the neck region.\n* lymph node size \\<10mm.\n\nExclusion Criteria:\n\n* patients treated before by radiotherapy / chemoradiotherapy\n* patients underwent surgery\n* artifacts'}, 'identificationModule': {'nctId': 'NCT04360993', 'briefTitle': 'Role of PET/MRI in Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'PET/CT and PET/MRI Based Treatment Modalities in the Modern Oncology', 'orgStudyIdInfo': {'id': 'Pécs/ Oncoradiology'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients underwent PET/CT & PET/MRI', 'description': 'Patients with head and neck cancer were underwent PET/CT and PET/MRI for staging, assessment and follow up', 'interventionNames': ['Radiation: Radiotherapy']}], 'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'Patients have received radiotherapy as a treatment modality for Head and neck cancer', 'armGroupLabels': ['Patients underwent PET/CT & PET/MRI']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Arpad Kovacs, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pecs'}, {'name': 'Cselik Zsolt, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Csolnoky Ferenc Kórház, Veszprém, Hungary'}, {'name': 'Omar Freihat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Doctoral school of health sciences, Pécs University, Hungary'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'Variable used in the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical investigator.', 'investigatorFullName': 'Omar Freihat', 'investigatorAffiliation': 'University of Pecs'}}}}