Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT03991533
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2019-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Retrospective Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-23', 'studyFirstSubmitDate': '2019-02-13', 'studyFirstSubmitQcDate': '2019-06-18', 'lastUpdatePostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'discriminatory value of MRI perfusion curve', 'timeFrame': 'preoperative', 'description': "differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'"}, {'measure': 'discriminatory value of MRI ADC', 'timeFrame': 'preoperative', 'description': "differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'"}, {'measure': 'discriminatory value of MRI D-value', 'timeFrame': 'preoperative', 'description': "differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer', 'Multiparametric MRI', 'Cervical Lymph Node']}, 'descriptionModule': {'briefSummary': 'The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.', 'detailedDescription': "Background:The locoregional control rates in patients with advanced head and neck cancer remain suboptimal. Accurate diagnosis of metastatic cervical lymph nodes remains challenging. Technological advances in magnetic resonance imaging (MRI) enable to quantify diffusion and perfusion of the tumour and its surrounding tissues, which could improve diagnostic performance.\n\nObjectives: The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.\n\nStudy design: a retrospective study will be set up to explore the diagnostic performance of the selected MRI parameters to differentiate between tumoural and non-tumoural cervical lymph nodes in patients with a histologically confirmed head and neck tumour ('affected group') or histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation ('control group').\n\nPatients will be screened for inclusion in the analysis if they had a routine preoperative multiparametric MRI, according to a standardised protocol, between the 1st of December 2016 and the 30th of September 2018. All MR images will be screened by the resident to select those patients with one or multiple clearly distinguishable metastatic cervical lymph node(s), which can be clearly correlated with the final pathology report. Other strict inclusion criteria are described in detail in the protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'affected group: Histopathologically proven SCC in the HN region control group: Histopathologically proven Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation in the HN region', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients that received a pretreatment multiparametric MRI according to a standardized protocol between December 2016 and December 2018\n* histophatologically proven SCC in the head and neck region\n* one or multiple clearly distinguishable cervical lymph node(s), that can be unambiguously correlated with the pathology report\n\nExclusion Criteria:\n\n* patients not fulfilling abovementioned criteria\n* patients with thyroid or skin cancer\n* considerable artefact on MRI\n* previous surgery, irradiation or chemotherapy in the HN region'}, 'identificationModule': {'nctId': 'NCT03991533', 'briefTitle': 'Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Retrospective Analysis', 'organization': {'class': 'OTHER', 'fullName': 'AZ Sint-Jan AV'}, 'officialTitle': 'Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer', 'orgStudyIdInfo': {'id': '2360'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'affected', 'description': 'patients with a histologically confirmed head and neck tumour', 'interventionNames': ['Other: multiparametric MRI']}, {'label': 'control', 'description': 'histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation', 'interventionNames': ['Other: multiparametric MRI']}], 'interventions': [{'name': 'multiparametric MRI', 'type': 'OTHER', 'description': 'preoperative multiparametric MRI', 'armGroupLabels': ['affected', 'control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Johan Abeloos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AZ Sint-Lucas Brugge'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AZ Sint-Jan AV', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Johan Abeloos', 'investigatorAffiliation': 'AZ Sint-Jan AV'}}}}