[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544511":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":38,"responsibleParty":123,"collaborators":20,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":127,"sex":133,"minAge":134,"maxAge":20,"enrollmentInfo":135,"targetDuration":20,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":145,"overallStatus":41,"whyStopped":20,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Abscint NV\u002FSA","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"68Ga-ABS011 PET\u002FCT","EXPERIMENTAL","All Hormone receptor positive\u002FHER2 negative, triple-negative or HER2 positive metastatic Breast Cancer (mBC) patients will undergo a HER2 targeted PET\u002FCT using 68Ga-ABS011 after completion of a 18F-FDG PET\u002FCT and lesion biopsy (and IHC\u002FISH analysis).",[13],"Diagnostic Test: 68Ga-NOTA-ABSCINT-HER2 PET\u002FCT",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","68Ga-NOTA-ABSCINT-HER2 PET\u002FCT","68Ga-ABS011, is a single domain antibody (sdAb) with the capability to bind HER2 tumor antigens very fast, while the unbound fraction is rapidly cleared from the blood. ABS011 is labeled with gallium-68, a short-lived isotope (68Ga, t1\u002F2: 68 min). Combining rapid targeting of HER2, fast clearance and low radiation burden make 68Ga-ABS011 is suited for specific tumor marker whole body PET\u002FCT imaging.",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Géraldine Gebhart","Institut Jules Bordet Brussels","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":24,"role":25},"Evandro De Azambuja",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":20,"email":33},"Karine Clauwaert","CONTACT","+32476536594","karine.clauwaert@abscint.com",{"name":35,"role":31,"phone":36,"phoneExt":20,"email":37},"Dieter Frijns","+32473337625","dieter.frijns@abscint.com",[39,58,75,83,91,99,110],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Medizinische Universität Innsbruck","RECRUITING","Innsbruck","Tyrol","A-6020","Austria","AT",{"type":48,"coordinates":49},"Point",[50,51],11.39454,47.26266,{"lat":51,"lon":50},[54],{"name":55,"role":31,"phone":56,"phoneExt":20,"email":57},"Daniel Egle, Prof.Dr.","0043 512 504 82477","ago.studienzentrale@i-med.ac.at",{"facility":59,"status":41,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"AZ Delta CHIREC","Brussels","Brussels Capital","1070","Belgium","BE",{"type":48,"coordinates":66},[67,68],4.34878,50.85045,{"lat":68,"lon":67},[71,73],{"name":72,"role":31,"phone":20,"phoneExt":20,"email":20},"C. Closset, Dr.",{"name":74,"role":31,"phone":20,"phoneExt":20,"email":20},"A. Awada, Prof.Dr.",{"facility":76,"status":41,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Cliniques Universitaires Saint-Luc",{"type":48,"coordinates":78},[67,68],{"lat":68,"lon":67},[81],{"name":82,"role":31,"phone":20,"phoneExt":20,"email":20},"F. Duhoux, Prof.Dr.",{"facility":84,"status":41,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"Free University Brussels (VUB)",{"type":48,"coordinates":86},[67,68],{"lat":68,"lon":67},[89],{"name":90,"role":31,"phone":20,"phoneExt":20,"email":20},"C. Fontaine, Dr.",{"facility":92,"status":41,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":93,"geoPoint":95,"contacts":96},"Institut Jules Bordet",{"type":48,"coordinates":94},[67,68],{"lat":68,"lon":67},[97],{"name":98,"role":31,"phone":20,"phoneExt":20,"email":20},"E. De Azambuja, Prof.Dr.",{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":63,"countryCode":64,"cosmosGeoPoint":105,"geoPoint":109,"contacts":20},"OLV Aalst","COMPLETED","Aalst","East-Flanders","9300",{"type":48,"coordinates":106},[107,108],4.0355,50.93604,{"lat":108,"lon":107},{"facility":111,"status":41,"city":112,"state":20,"zip":20,"country":63,"countryCode":64,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"University Hospital Gasthuisberg","Leuven",{"type":48,"coordinates":114},[115,116],4.70093,50.87959,{"lat":116,"lon":115},[119,121],{"name":120,"role":31,"phone":20,"phoneExt":20,"email":20},"Karolien Goffin, Prof.Dr.",{"name":122,"role":31,"phone":20,"phoneExt":20,"email":20},"Hans Wildiers, Prof.Dr.",{"type":124,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100544511","phase-2-her2-targeted-molecular-imaging-in-mbc-and-other-metastatic-solid-carcinomas-using-68ga-abs011-100544511",false,"NCT06369831","HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011","Evaluating the Diagnostic Performance of Human Epidermal Growth Factor Receptor 2 (HER2) Targeted Positron Emission Tomography and Computed Tomography (PET\u002FCT) With 68Ga-ABS011 in Metastatic Breast Cancer (mBC) and Other Metastatic Solid Carcinomas.","HERMIA","Inclusion Criteria:\n\n1. Adult (≥ 18 years at the time of informed consent signature) male or female patient\n2. Patient with confirmed de novo or pre-treated metastatic solid tumors (multiple previous treatment lines in metastatic setting are allowed).\n\n   2.1. Patients with documented hormone receptor positive\u002FHER2 negative, triple-negative or HER2 positive mBC that could become eligible for commercially available HER2 targeted monotherapy (i.e. through confirmation of HER2 IHC non-0 status assessed during the course of the study) or 2.2 Other metastatic solid tumors, not necessarily eligible for commercially available HER2 targeted monotherapy .\n3. Patient presenting with at least one target biopsiable, FDG positive , non-liver metastatic lesion of ≥15 mm defined on ceCT (as part of screening 18F-FDG PET\u002FceCT assessment).\n4. Patient willing to undergo at least one tumor biopsy.\n5. Male patients able to father children and female patients of childbearing potential agree to use effective methods of contraception during the diagnostic and SOCa treatment follow-up study phases.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to\n7. Ability and willingness of the research participant to provide written informed consent.\n\nExclusion Criteria:\n\n1. Primary (non-metastatic) solid tumor cancer.\n2. Patient not willing to undergo at least one tumor biopsy. Note: A recent biopsy and accompanied locally assessed IHC\u002FISH analyses, completed before screening, will not be accepted for study purposes.\n3. 18F-FDG PET\u002FceCT completed before screening and patient not willing to repeat this assessment.\n4. Metastatic setting 18F-FDG PET\u002FceCT indicating that the identified tumor lesions cannot be biopsied due their location and\u002For tissue type and\u002For an increased risk for serious comorbidities.\n5. Brain and liver metastases are the sole sites of metastatic disease.\n6. Life expectancy lower than 3 months.\n7. Pregnancy or breastfeeding.\n8. Inadequate organ function, suggested by clinically relevant abnormal laboratory results:\n\n   1. Significantly impaired renal function defined as estimated Glomerular Filtration Rate (GFR) \\\u003C30 ml\u002Fmin\u002F1.73m2.\n   2. Absolute neutrophil count \\\u003C1,500 cells\u002Fmm3.\n   3. Total bilirubin \\~1.5 x Upper Limit of Normal (ULN) (unless the patient has documented Gilbert's syndrome).\n   4. Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) or Alanine aminotransferase (ALT)\u002F serum glutamic pyruvic transaminase (SGPT) \\>5.0 x ULN.\n9. Patients with a known hypersensitivity to any of the investigational medicinal product (IMP) components or packaging.\n10. Patients with increased risks of bleeding or other complications from biopsies (e.g. patients under anticoagulation therapy for whom temporary discontinuation of this therapy cannot be safely performed).\n11. Patients with a known hypersensitivity or contraindication for iodinated contrast media (iCM) which cannot be controlled by taking prophylactic measures (e.g. temporary treatment interruption or introduction of adequate pre-medication).\n12. Patients who cannot undergo PET\u002FCT scanning (including but not limited to body size and claustrophobia).\n13. Any condition that in the opinion of the investigator may significantly interfere with study compliance (including but not limited to psychological or psychiatric, social or geographical condition potentially hampering compliance with the study requirements).","ALL","18 Years",{"count":136,"type":137},60,"ESTIMATED","INTERVENTIONAL",[140],"PHASE2","This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PET\u002FCT in determining the HER2 expression status, and to evaluate 68Ga-ABS011's ability to drive changes in therapeutic treatment. 68Ga-ABS011 will be compared to the current standard of care (SOCa) diagnostic methods including immunohistochemistry (IHC), in situ hybridization (ISH) and imaging tools used for treatment response follow-up including Fluorodeoxyglucose F-18 (18F-FDG) positron emitted tomography (PET) and contrast enhanced computed tomography (ceCT).",[143,144],"Metastatic Breast Cancer","Metastatic Solid Cancer",[146,147,148,149,150,151,152,153,154],"radiolabeled","single domain antibody","68Ga","Gallium-68","HER2","PET\u002FCT","metastatic cancer","metastatic solid tumor","metastatic breast cancer","2026-06-01",{"date":157,"type":158},"2026-06-02","ACTUAL",{"date":160,"type":158},"2024-09-12",{"date":162,"type":137},"2026-09",{"name":5,"class":6},7]