Nctid:
NCT06612047
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011471", "term"=>"Prostatic Neoplasms"}], "ancestors"=>[{"id"=>"D000005834", "term"=>"Genital Neoplasms, Male"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000005832", "term"=>"Genital Diseases, Male"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000011469", "term"=>"Prostatic Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M14335", "name"=>"Prostatic Neoplasms", "asFound"=>"Prostate Cancer", "relevance"=>"HIGH"}, {"id"=>"M8946", "name"=>"Genital Neoplasms, Male", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8944", "name"=>"Genital Diseases, Male", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14333", "name"=>"Prostatic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>150}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-08", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-21", "studyFirstSubmitDate"=>"2024-09-21", "studyFirstSubmitQcDate"=>"2024-09-21", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-09-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer.", "timeFrame"=>"through study completion, an average of 1 month", "description"=>"Definitions: csPCa, Gleason score ≥ 3+4， ISUP grade ≥ 2; agPCa, Gleason score ≥ 3+3， ISUP grade ≥ 1.\n\nEvaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value."}], "secondaryOutcomes"=>[{"measure"=>"Evaluation of the reliability (repeatability) of the diagnostic test.", "timeFrame"=>"through study completion, an average of 1 month", "description"=>"The inter-reader agreement was evaluated using Cohen's kappa analysis (Cohen's kappa coefficeint, P-value and 95%CI)"}, {"measure"=>"Comparative analysis of the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the stage of prostate cancer", "timeFrame"=>"through study completion, an average of 2 months", "description"=>"Accuracy of prostate capsule invasion, seminal vesicle invasion and pelvic lymph node metastasis."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Prostate cancer", "prostate biospy", "Biparametric Magnetic Resonance", "Prostate Imaging-Reporting and Data System", "Diagnosis"], "conditions"=>["Prostate Cancer"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to compare 5.0T and 3.0T biparametric magnetic resonance imaging in the diagnosis of prostate cancer. The main aims of this study are:\n\n* Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer. Preliminarily evaluate the value of 5.0TbpMRI in diagnosing prostate cancer.\n* Compare and analyze the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the T stage of prostate cancer. Preliminary evaluation of the value of 5.0TbpMRI in determining the tumor stage of prostate cancer.\n\nThe data of participants was collected prospectively.", "detailedDescription"=>"The methods currently recommended by the guidelines for early diagnosis of prostate cancer mainly include rectal examination, serum prostate-specific antigen detection, transrectal prostate ultrasound, and multi-parameter magnetic resonance imaging. However, these methods lack sufficient specificity for the diagnosis of prostate cancer. Therefore, prostate biopsy is still the gold standard for the diagnosis of prostate cancer. mpMRI has good accuracy in detecting clinically significant prostate cancer, but mpMRI is difficult to identify lesions with a tumor diameter of less than 5 mm, and false positive results may occur for benign diseases such as prostatitis. The magnetic field strength of mpMRI magnetic resonance scanners commonly used in clinical practice is mostly 1.5T or 3.0T. The application of 3.0T magnetic resonance allows patients to no longer accept the use of rectal coils and makes the examination images clearer, making it the most commonly used magnetic field strength for mpMRI. The main problems of 3.0T prostate magnetic resonance examinations are low specificity (false positive results) and insufficient accuracy in determining tumor staging. At present, there is no research and exploration on the use of 5.0T magnetic resonance in the diagnosis of prostate cancer in the world. This study intends to analyze and compare the differences between 5.0TbpMRI and 3.0TbpMRI in the diagnosis of prostate cancer through a prospective, paired-design diagnostic trial, and try to explore whether 5.0TbpMRI can improve the limitations of 3.0TbpMRI in the diagnosis of prostate cancer."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"This study mainly screened patients who need to complete mainly included serum PSA test, digital rectal examination, and 3.0TbpMRI and with indications of prostate biopsy. An informed consent conversation was conducted with the patient. After the patient fully understood the content of the study and signed the informed consent form, the researcher guided and arranged the 5.0TbpMRI examination throughout the process. All patients should complete the prostate biopsy according to the routine diagnosis and treatment process. The pathological diagnosis results of the prostate biopsy are the diagnostic gold standard of this study. The accuracy of 3.0TbpMRI and 5.0TbpMRI in preoperative prostate cancer tumor staging based on the final pathological results of radical prostatectomy.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. The patient has at least one indication for prostate biopsy (Chinese expert consensus on prostate biopsy (2022 edition) );\n2. The primary prostate cancer has no other cancer history;\n3. The 3.0TbpMRI examination was completed, and the images were clear and accessible;\n4. The 5.0TbpMRI examination was further completed, and the images were clear and accessible;\n5. The patient fully understands the relevant content of the study and voluntarily signs the informed consent.\n\nExclusion Criteria:\n\n1. The patient has contraindications to MRI examination, such as metal plates and heart stents in the body;\n2. The patient does not have an indication for prostate biopsy or refuses biopsy;\n3. The patient has contraindications to prostate biopsy;\n4. 3.0T MRI considers that the patient has multiple lymph node or bone metastases;\n5. The patient has undergone other prostatic surgery in the past;\n6. The patient is unable to cooperate, has communication barriers, or refuses to sign the informed consent form."}, "identificationModule"=>{"nctId"=>"NCT06612047", "acronym"=>"5TbpMRI", "briefTitle"=>"Comparison of 5.0T and 3.0T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer", "organization"=>{"class"=>"OTHER_GOV", "fullName"=>"Anhui Provincial Hospital"}, "officialTitle"=>"Comparison of 5.0T and 3.0T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer: A Prospective, Single Center and Paired-design Diagnostic Study", "orgStudyIdInfo"=>{"id"=>"2024-ky290"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Patients with clinical suspicion of prostate cancer undergo 5.0T and 3.0T bpMRI", "description"=>"All enrolled patients need to undergo 5.0TbpMRI and 3.0TbpMRI (within one month). The magnetic resonance imaging sequences mainly include T1WI, multi-plane T2WI and multi-b-value DWI images.", "interventionNames"=>["Procedure: Prostate biopsy"]}], "interventions"=>[{"name"=>"Prostate biopsy", "type"=>"PROCEDURE", "description"=>"All patients were required to underwent transperineal prostate biopsy (Systemetic + Targeted) and have corresponding pathological diagnosis results.", "armGroupLabels"=>["Patients with clinical suspicion of prostate cancer undergo 5.0T and 3.0T bpMRI"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Changming Wang, M.D.", "role"=>"CONTACT", "email"=>"wcmurologist@mail.ustc.edu.cn", "phone"=>"15840256553"}, {"name"=>"Jun Xiao, M.D.", "role"=>"CONTACT", "email"=>"anhuiurology@126.com", "phone"=>"13956934087"}], "overallOfficials"=>[{"name"=>"Jun Xiao, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"The First Affiliated Hospital of USTC"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Anhui Provincial Hospital", "class"=>"OTHER_GOV"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor, Chief Physician", "investigatorFullName"=>"XiaoJun", "investigatorAffiliation"=>"Anhui Provincial Hospital"}}}}
