[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557617":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":46,"centralContacts":51,"locations":58,"responsibleParty":75,"collaborators":77,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":56,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":56,"enrollmentInfo":89,"targetDuration":56,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":56,"overallStatus":60,"whyStopped":56,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"MegaPro Biomedical Co. Ltd.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose cohort 1","EXPERIMENTAL","pre- and post-enhanced MRI",[13],"Drug: MPB-2043 of 0.5 mg\u002Fkg",{"label":15,"type":10,"description":11,"interventionNames":16},"Dose cohort 2",[17],"Drug: MPB-2043 of 1.0 mg\u002Fkg",{"label":19,"type":10,"description":11,"interventionNames":20},"Dose cohort 3",[21],"Drug: MPB-2043 of 2.0 mg\u002Fkg",{"label":23,"type":10,"description":11,"interventionNames":24},"Dose cohort 4",[25],"Drug: MPB-2043 of 3.0 mg\u002Fkg",[27,34,38,42],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","MPB-2043 of 0.5 mg\u002Fkg","Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.",[9],[33],"MPB-2043 enhanced MRI",{"type":28,"name":35,"description":30,"armGroupLabels":36,"otherNames":37},"MPB-2043 of 1.0 mg\u002Fkg",[15],[33],{"type":28,"name":39,"description":30,"armGroupLabels":40,"otherNames":41},"MPB-2043 of 2.0 mg\u002Fkg",[19],[33],{"type":28,"name":43,"description":30,"armGroupLabels":44,"otherNames":45},"MPB-2043 of 3.0 mg\u002Fkg",[23],[33],[47],{"name":48,"affiliation":49,"role":50},"Pei-Jen Lou, MD., PhD","National Taiwan University Hospital","PRINCIPAL_INVESTIGATOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Jill Tsai, MD","CONTACT","+886-35910360",null,"jilltsai@megaprobio.com",[59],{"facility":49,"status":60,"city":61,"state":56,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Taipei","100","Taiwan","TW",{"type":66,"coordinates":67},"Point",[68,69],121.52639,25.05306,{"lat":69,"lon":68},[72],{"name":48,"role":54,"phone":73,"phoneExt":56,"email":74},"+886-2-2312-3456","pjlou@ntu.edu.tw",{"type":76,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR",[78],{"name":49,"class":79},"OTHER","100557617","phase-1-pilot-study-of-mpb-2043-enhanced-mri-for-nodal-staging-in-head-and-neck-squamous-cell-carcinomas-100557617",false,"NCT06540443","Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas","A Pilot Feasibility Study of MPB-2043 Enhanced Magnetic Resonance Imaging (MRI) for Nodal Staging in Subjects With Head and Neck Squamous Cell Carcinomas","Inclusion Criteria:\n\n* Subjects aged 20 years and above\n* Subjects with histologically proven head and neck squamous cell carcinomas or with suspicious metastatic lymph nodes (≥ pathological T-stage 1 and 2) without previous treatment by surgery\n* Based on the site's clinical practice, subjects require lymphadenectomy treatment within 8 weeks.\n* Subjects must be nonlactating.\n* Subjects must be able to understand and be willing to sign a written informed consent document.\n* Subjects must be able to comply with the study protocol.\n\nExclusion Criteria:\n\n* Subjects with contraindications to MRI\n* Subjects with a serious allergic history or known allergy to similar ingredients of the study contrast agent (i.e., Gd-based, SPIO particles, and iodinated contrast agents).\n* Subjects obtained gadolinium-enhanced MRI ≤ 7 days before the enrollment.\n* Subjects who participated in another imaging-related clinical trial 30 days prior to the study enrollment.\n* Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption, and elimination of investigational contrast agent.\n* Subjects with kidney disease or impairment.\n* Subjects with liver or spleen disease or impairment based on other clinical imaging, such as CT or gadolinium contrast MRI, and clinical laboratory results.\n* Subjects with active hepatitis B or hepatitis C infection.\n* Subjects with bone marrow disorders or a history of a bone marrow transplant.","ALL","20 Years",{"count":90,"type":91},24,"ESTIMATED","INTERVENTIONAL",[94],"PHASE1","This study evaluates the safety and effectiveness of MPB-2043, a superparamagnetic iron oxide (SPIO) contrast agent, for enhancing MRI in detecting metastatic lymph nodes in head and neck cancer. The study compares four doses of MPB-2043 (0.5 mg\u002Fkg, 1 mg\u002Fkg, 2 mg\u002Fkg, and 3 mg\u002Fkg) and assesses the optimal timing for post-dose imaging using T1\u002FT2\u002FT2\\*-weighted sequences to improve the accuracy of nodal staging.",[97,98],"Head and Neck Squamous Cell Carcinoma","Lymph Node Metastasis","2025-05-05",{"date":101,"type":102},"2025-05-08","ACTUAL",{"date":104,"type":102},"2024-12-19",{"date":106,"type":91},"2026-09",{"name":5,"class":6},1]