Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-29 @ 11:51 PM
Study NCT ID:
NCT03212027
Status:
UNKNOWN
Last Update Posted:
2017-07-18
First Post:
2017-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Prediction of of Thymic Epithelial Tumors by Diffusion-Weighted MR Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536905', 'term': 'Thymic epithelial tumor'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-07-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-13', 'studyFirstSubmitDate': '2017-07-06', 'studyFirstSubmitQcDate': '2017-07-06', 'lastUpdatePostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Different DWI parameters in thymic epithelial tumors', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'To acquire aquaporins expression level of thymic epithelial tumors', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['apparent diffusion coefficient', 'aquaporins'], 'conditions': ['Thymic Epithelial Tumor']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to analyze aquaporins expression of thymic epithelial tumors and to compare them with apparent diffusion coefficient(ADC) from ultra-high b-values, and to test a possibility of use of ADCuh to identify the pathological type of tumor.', 'detailedDescription': 'Magnetic resonance (MR) diffusion-weighted imaging (DWI) measures water diffusion in biological tissue. The quantification of diffusion is described by the apparent diffusion coefficient (ADC),which largely depends on the number and separation of barriers.Thus, ADC can provide information regarding tissue microstructure.\n\nAccording to the literature, ADC is also related to cell membrane permeability for water molecules.It is well known that cellular water transport depends on aquaporins (AQPs).In general,the expression of aquaporins might differ in several pathologic disorders. With reference to this fact,we hypothesize that AQPs expression may influence ADC in thymic epithelial tumors(TETs).Therefore,the aim of the present study is to analyze possible associations between ADC from ultra-high b-values and AQPs expression(ADCuh) in TETs and to use ADCuh to identify the pathological type of tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with thymic epithelial tumors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no use of corticosteroid drugs;\n* no MRI contraindication;\n* no infection or fever;\n* tumor diameter is greater than 2cm.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03212027', 'briefTitle': 'Preoperative Prediction of of Thymic Epithelial Tumors by Diffusion-Weighted MR Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'Preoperative Prediction of the Pathological Classification of Thymic Epithelial Tumors by Apparent Diffusion Coefficient Using Ultra-high B-values', 'orgStudyIdInfo': {'id': '2016SF-211'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with low-risk thymomas', 'description': 'low-risk thymomas include types A, AB, and B1 thymomas'}, {'label': 'Patients with high-risk thymomas', 'description': 'high-risk thymomas include types B2 and B3 thymomas'}, {'label': 'Patients with thymic carcinomas', 'description': 'thymic carcinomas also called types C thymomas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}