[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640415":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":51,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":66,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm",null,"Women diagnosed with breast cancer by pathological diagnosis from core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months who will undergo surgery (without preoperative neoadjuvant chemotherapy).",[13],"Diagnostic Test: PET-MRI (PET\u002FMR)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","PET-MRI (PET\u002FMR)","1. The study participants will receive pre-treatment whole-body PET\u002FMR and breast PET\u002FMR examinations.\n2. The whole-body PET\u002FMR.\n3. PET\u002FMR of the breast.\n4. The whole-body FDG PET\u002FMR, and the breast FCH PET\u002FMR will be performed on different days (interval at least 2 days).\n5. The study results will be interpreted by board certified diagnostic radiologists and nuclear medicine physicians, and relayed to the patient's physicians for reference of clinical management.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Jane Wang, M.D.","CONTACT","+886938591583","jwang2@vghtpe.gov.tw",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":31,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Taipei Veterans General Hospital","RECRUITING","Taipei","Taiwan","11217","TW",{"type":35,"coordinates":36},"Point",[37,38],121.52639,25.05306,{"lat":38,"lon":37},[41,42,44,47,49],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"name":22,"role":43,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":45,"role":46,"phone":10,"phoneExt":10,"email":10},"Ling-Ming Tseng, M.D","SUB_INVESTIGATOR",{"name":48,"role":46,"phone":10,"phoneExt":10,"email":10},"Ko-Han Lin, M.D.",{"name":50,"role":46,"phone":10,"phoneExt":10,"email":10},"Yi-Fang Tsai, M.D.",{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100640415","fluorocholine-petmr-in-breast-cancer-100640415",false,"NCT07587086","Fluorocholine PET\u002FMR in Breast Cancer","Use of Imaging Markers by Fluorocholine PET\u002FMR to Predict Molecular Subtypes and Clinical Outcomes of Breast Cancer: A Pilot Study","Inclusion Criteria:\n\n* Women aged 25-75 years old.\n* Women diagnosed with breast cancer by pathological diagnosis from a core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy).\n* Women whose ECOG performance status between 0-2 and life expectancy at least 3 months.\n\nExclusion Criteria:\n\n* Women who are unable to cooperate with the examinations\n* Women who are pregnant, lactating or are planning to be pregnant\n* Women with estimated glomerular filtration rate (eGFR) \\\u003C 60 ml\u002Fmin\u002F1.73m2 or acute renal failure within 3 months, past history of renal dialysis.\n* Past history of claustrophobia\n* Past history of anaphylactoid reactions to MRI contrast agents or PET tracer agents.\n* Women with cardiac pacemaker, aneurysmal clip, mechanical valve replacement, recently applied coronary artery stent (within 3 months).\n* Past history of breast cancer or other malignancy within 5 years.\n* Women who underwent chemotherapy within a year.\n* Women who are not suitable to join the study according to the assessment by investigators.","FEMALE","25 Years","75 Years",{"count":64,"type":65},195,"ESTIMATED","40 Weeks","OBSERVATIONAL","Objectives:\n\nOur study is conducted to use the pre-treatment Fluorocholine (FCH) Positron emission tomography\u002Fmagnetic resonance (PET\u002FMR) imaging in breast cancer patients, to investigate whether the conventional PET\u002FMR imaging markers (maximum standardized uptake value \\[SUVmax\\], MR spectroscopy-derived choline analysis, dynamic contrast-enhanced MRI, apparent diffusion coefficient \\[ADC\\] analysis), and FCH PET\u002FMR radiomic features, deep learning (DL) analysis are associated with molecular subtypes, clinical outcomes, treatment response, survival, and which parameters are more accurate for predictive purposes.\n\nPrimary study purposes:\n\n-To investigate whether the pre-treatment FCH PET\u002FMR imaging parameters are associated with molecular subtypes of breast cancers, and to evaluate the diagnostic performance for predictive purposes.\n\nSecondary study purposes:\n\n-To investigate whether the pre-treatment FCH PET\u002FMR imaging parameters are associated with the factors related to clinical outcomes (histologic grade, prognosis) and to analyze which parameters are more accurate for predictive purposes.\n\nTest drug:\n\nName: 18F- Fluorocholine (18F-FCH) Dosage form: N-(\\[18F\\]fluoromethyl)-2-hydroxy-N,N-dimethylethan-1-aminium Strength: 3-5 MBq\u002Fkg per patient (5-6 mCi\u002FmL at time of injection (TOI)) Dosage and administration: Intravenous injection.fluoromethyl\n\nSelection criteria:\n\n1. Women aged 25-75 years old.\n2. Women diagnosed with breast cancer by pathological diagnosis from a core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy).\n3. Women whose Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and life expectancy at least 3 months.",[70,71],"Breast Neoplasms","Female",[73,74,75,76],"Breast Cancer","FCH(18F- Fluorocholine)","Radiomics","PET\u002FMRI","2026-07-02",{"date":79,"type":80},"2026-07-06","ACTUAL",{"date":82,"type":80},"2022-06-14",{"date":84,"type":65},"2028-07-31",{"name":5,"class":6},1]