Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-02-12 @ 8:17 PM
Study NCT ID:
NCT04962269
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2021-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of DWI in Diagnosis of Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-04', 'studyFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2021-07-04', 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pathological diagnosis', 'timeFrame': '2013.10-2018.6', 'description': 'prostate cancer or benign prostatic hyperplasia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['benign prostatic hyperplasia', 'Diffusion weighted imaging'], 'conditions': ['Prostate Cancer', 'Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'This study compared the performance of different models of multiple b-value DWI in diagnosing prostate cancer.', 'detailedDescription': 'Diffusion weighted imaging (DWI) plays an important role in the diagnosis and stratification of prostate cancer. Traditional DWI apply the apparent diffusion coefficient (ADC) to reflect the diffusion of tissue water, which is a parameter calculated by a monoexponential model with 2b values. In recent years, the development of multiple b-value DWI facilitates the appearance of many new mathematical models. Different models have different features, but their value of applications in prostate cancer still need to be confirmed. This study was aiming to: (1) compare the parameters derived from monoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model between prostate cancer and benign prostatic hyperplasia; (2) compare the difference of these parameters between low-grade (Gleason score ≤ 3+4) and high-grade (Gleason score ≥ 4+3) cancer; (3) find whether these parameters derived from new models are superior to ADC derived from traditional monoexponetial model.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with prostatic diseases confirmed as prostate cancer or benign prostatic hyperplasia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The exam including T1WI、T2WI and multiple b-value DWI.\n2. Comfired by pathology as prostate cancer or benign prostatic hyperplasia in one month after the MRI exam.\n\nExclusion Criteria:\n\n* 1.No Gleason score data. 2.Awful quality of imagings or artifacts affectting diagnosis. 3.No lesion larger than 0.5cm. 4.Any surgery or treatment before MRI exam. 5.Biopsy in 4 weeks before MRI exam.'}, 'identificationModule': {'nctId': 'NCT04962269', 'briefTitle': 'Application of DWI in Diagnosis of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Different Models of Multiple B-value DWI and Their Applications in Diagnosis of Prostate Cancer', 'orgStudyIdInfo': {'id': 'M2019176'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'prostate cancer', 'description': 'The patient was pathologically diagnosed with prostate cancer', 'interventionNames': ['Diagnostic Test: MRI']}, {'label': 'benign prostatic hyperplasia', 'description': 'The patient was pathologically diagnosed with benign prostatic hyperplasia'}], 'interventions': [{'name': 'MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'monoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model', 'armGroupLabels': ['prostate cancer']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jianyu Liu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}