protocolSection identificationModule nctId: NCT06369831, orgStudyIdInfo id: ABS011-1, secondaryIdInfos id: 2024-511419-22-00, type: CTIS, briefTitle: HER2 Targeted Molecular Imaging in mBC Using 68Ga-ABS011, acronym: HERMIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: ABSCINT NV/SA, class: INDUSTRY, descriptionModule briefSummary: This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PET/CT 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)., conditionsModule conditions: Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Interventional, prospective, single arm radio-diagnostic study. Driven by number of biopsied lesions (and not by number of patients), primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-NOTA-ABSCINT-HER2 PET/CT, outcomesModule primaryOutcomes measure: positive, negative, and overall diagnostic agreement between 68Ga-ABS011 PET/CT and the standard of care IHC (and ISH) HER2 status test., secondaryOutcomes measure: Safety of 68Ga-ABS011., secondaryOutcomes measure: Change in treatment management, secondaryOutcomes measure: reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (Early tumor shrinkage), secondaryOutcomes measure: reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (metabolic response), secondaryOutcomes measure: Tumor heterogeneity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OLV Aalst, city: Aalst, state: East-Flanders, zip: 9300, country: Belgium, contacts name: G. Huygh, Dr., role: CONTACT, geoPoint lat: 50.93604, lon: 4.0355, locations facility: AZ Delta, city: Brussels, zip: 1070, country: Belgium, contacts name: C. Closset, Dr., role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Cliniques Universitaires Saint-Luc, city: Brussels, zip: 1070, country: Belgium, contacts name: F. Duhoux, Prof., role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Free University Brussels (VUB), city: Brussels, zip: 1070, country: Belgium, contacts name: C. Fontaine, Dr., role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Institut Jules Bordet, city: Brussels, zip: 1070, country: Belgium, contacts name: E. De Azambuja, Prof., role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False