[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100388039":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":59,"collaborators":24,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":24,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":24,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":24,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Herceptin monotherapy cohort","EXPERIMENTAL","Herceptin monotherapy cohort. Locally advanced HER2+ breast cancer patients receiving neoadjuvant Herceptin monotherapy prior to combination therapy will undergo three contrast-enhanced \\[18F\\]FMISO PET\u002FMRI scans. Each imaging session will be identical. Imaging session one will be after diagnosis and before beginning monotherapy. Imaging session two will be within 10 days prior to beginning combination therapy with targeted HER2 agents. Imaging session three will be within 10 days prior to beginning the second round of combination therapy with targeted HER2 agents.",[13],"Drug: [18F]FMISO PET\u002FMRI imaging",{"label":15,"type":10,"description":16,"interventionNames":17},"Combination therapy cohort","Locally advanced HER2+ breast cancer patients that receiving neoadjuvant combination therapy including Herceptin will undergo two contrast-enhanced \\[18F\\]FMISO PET\u002FMRI imaging. Imaging session one will be after diagnosis and before beginning combination therapy. Imaging session two will be within 10 days prior to beginning the second round of combination therapy with targeted HER2 agents.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","[18F]FMISO PET\u002FMRI imaging","\\[18F\\]FMISO PET\u002FMRI imaging",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"Jonathan McConathy, MD, PhD","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Anna Sorace, PhD","CONTACT","205-934-3116","asorace@uabmc.edu",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Sebastian Eady","2059962636","smeady@uabmc.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35249","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-86.80249,33.52066,{"lat":52,"lon":51},[55],{"name":56,"role":32,"phone":57,"phoneExt":24,"email":58},"April Riddle, BSRT","205-934-6504","ariddle@uabmc.edu",{"type":28,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Jonathan E McConathy","Director, Advanced Imaging Facility, Director, Division of Molecular Imaging and Therapeutics Professor, Division of Molecular Imaging and Therapeutics","100388039","phase-1-monitoring-her2-breast-cancer-neoadjuvant-treatment-with-advanced-petmri-100388039",false,"NCT04332588","Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET\u002FMRI","Inclusion Criteria:\n\n1. Patients must be ≥ 18 years old and ≤ 75 years old\n2. HER2+ breast cancer determined on primary tumor by a local pathology laboratory and defined as IHC score 3+ and\u002For positive by ISH (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility\n3. Locally advanced stage II-III HER2+ breast cancer patients eligible for neoadjuvant therapy who are naïve to beginning treatment\n4. Estimated life expectancy of greater than one year\n5. Patients must have one lesion with RECIST measurable disease (great than 1 cm in diameter)\n\nExclusion Criteria:\n\n1. Inability to provide informed consent F\n2. Weight over 350 lbs., due to the scanner bore size\n3. Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum β-hCG pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 48 hours of each PET imaging study.\n4. Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)\n5. Unable to lie still on the imaging table for one (1) hour\n6. contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)","FEMALE","18 Years",{"count":71,"type":72},25,"ESTIMATED","INTERVENTIONAL",[75],"PHASE1","The purpose of the study is to see if using an investigational drug called \\[18F\\]FMISO with PET\u002FMRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and is not a treatment study. The results of this study will not change a patient's clinical treatment plan but it may help physicians and researchers better understand how best to treat patients with breast cancer in the future.",[78],"HER2-positive Breast Cancer","2026-06-12",{"date":81,"type":82},"2026-06-16","ACTUAL",{"date":84,"type":82},"2022-03-25",{"date":86,"type":72},"2027-08",{"name":5,"class":6},1]