[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542949":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":40,"studyPopulation":32,"armGroups":41,"interventions":48,"overallOfficials":54,"centralContacts":58,"locations":67,"responsibleParty":148,"collaborators":32,"id":150,"slug":32,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":151,"sex":157,"minAge":158,"maxAge":32,"enrollmentInfo":159,"targetDuration":32,"studyType":162,"phases":163,"briefSummary":36,"conditions":164,"keywords":32,"overallStatus":70,"whyStopped":32,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Institut Curie","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Area under the ROC curve","To measure the performance of 68Ga-FAPI-46 PET\u002FCT imaging to predict complete histological response after neoadjuvant chemotherapy plus Pembrolizumab, in terms of Area under the ROC curve (AUC of the ROC curve).","6 months",[14,18,21,25,29],{"measure":15,"description":16,"timeFrame":17},"Comparison of 68Ga-FAPI-46 PET\u002FCT and 18F-FDG PET\u002FCT performances","Comparison of 68Ga-FAPI-46 PET\u002FCT and 18F-FDG PET\u002FCT performances by detecting metastases","Baseline",{"measure":19,"description":20,"timeFrame":17},"Evaluation of 68Ga-FAPI-46 PET\u002FCT and 18F-FDG PET\u002FCT performances","Comparison of 68Ga-FAPI-46 PET\u002FCT and 18F-FDG PET\u002FCT performances by evaluating the tumor burden (TFTV : total FAP expression tumor volume and TMTV : total metabolic tumor volume).",{"measure":22,"description":23,"timeFrame":24},"Comparison of 68Ga-FAPI-46 PET\u002FCT and 18F-FDG PET\u002FCT predictive performances","Comparison of 68Ga-FAPI-46 PET\u002FCT and 18F-FDG PET\u002FCT predictive performances, separately and combined at the end of neoadjuvant treatment cycles.","Day 168",{"measure":26,"description":27,"timeFrame":28},"Comparison of 68Ga-FAPI-46 PET\u002FCT and 18F-FDG PET\u002FCT pronostic performances","Comparison of 68Ga-FAPI-46 PET\u002FCT and 18F-FDG PET\u002FCT pronostic performances, separately and combined at the end of the follow-up","5 years",{"measure":30,"description":31,"timeFrame":17},"Evaluation of predictive model performance combining 68Ga-FAPI-46 PET\u002FCT and 18F-FDG PET\u002FCT","Evaluation of predictive model performance combining 68Ga-FAPI-46 PET\u002FCT and 18F-FDG PET\u002FCT imaging data, using sensitivity, specificity, positive and negative predictive values and area under the ROC curve (AUC of the ROC curve)",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"NA","SINGLE_GROUP","Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET\u002FCT imaging in patients with early-stage high-risk TNBC.","DIAGNOSTIC",{"masking":39,"maskingDescription":32,"whoMasked":32},"NONE","Prospective multicenter study evaluating the prediction of histological response of pembrolizumab in combination with neoadjuvant chemotherapy by pre-treatment 68Ga-FAPI-46 PET\u002FCT imaging in patients with early-stage high-risk TNBC.\n\nPatients will receive the newly established standard of care of neoadjuvant pembrolizumab 200 mg Q3W given with 4 cycles of paclitaxel + carboplatin, then with 4 cycles of doxorubicin or epirubicin + cyclophosphamide. After definitive surgery, patients will receive adjuvant pembrolizumab for 9 cycles or until recurrence or unacceptable toxicity.\n\nThe 68Ga-FAPI-46 PET\u002FCT scan will be performed for each patient pre-therapy and on the same machine as the 18F-FDG PET\u002FCT scan and within 14 days before the start of treatment.",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"Triple Negative Breast Cancer","EXPERIMENTAL","Patients with early-stage high-risk Triple Negative Breast Cancer",[47],"Procedure: 68Ga-FAPI-46 PET\u002FCT imaging",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":32},"PROCEDURE","68Ga-FAPI-46 PET\u002FCT imaging","The 68Ga-FAPI-46 PET\u002FCT scan will be performed for each patient pre-therapy and on the same machine as the 18F-FDG PET\u002FCT scan and within 14 days before the start of treatment.",[43],[55],{"name":56,"affiliation":5,"role":57},"Romain-David SEBAN","PRINCIPAL_INVESTIGATOR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":32,"email":63},"Sandra Nespoulous","CONTACT","0147111654","drci.promotion@curie.fr",{"name":65,"role":61,"phone":66,"phoneExt":32,"email":63},"Marie-Emmanuelle LEGRIER","0156245649",[68,85,98,108,121,134],{"facility":69,"status":70,"city":71,"state":32,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Hôpital Privé d'Antony","RECRUITING","Antony","92160","France","FR",{"type":76,"coordinates":77},"Point",[78,79],2.29668,48.75329,{"lat":79,"lon":78},[82,84],{"name":83,"role":61,"phone":32,"phoneExt":32,"email":32},"Amal GHOUADNI, MD",{"name":83,"role":57,"phone":32,"phoneExt":32,"email":32},{"facility":86,"status":70,"city":87,"state":32,"zip":88,"country":73,"countryCode":74,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Institut Curie -site Paris","Paris","75005",{"type":76,"coordinates":90},[91,92],2.3488,48.85341,{"lat":92,"lon":91},[95,97],{"name":96,"role":61,"phone":32,"phoneExt":32,"email":32},"Nina JEHANNO, MD",{"name":96,"role":57,"phone":32,"phoneExt":32,"email":32},{"facility":99,"status":70,"city":87,"state":32,"zip":100,"country":73,"countryCode":74,"cosmosGeoPoint":101,"geoPoint":103,"contacts":104},"GH Diaconesses Croix Saint-Simon","75020",{"type":76,"coordinates":102},[91,92],{"lat":92,"lon":91},[105,107],{"name":106,"role":61,"phone":32,"phoneExt":32,"email":32},"Laure HIRSCH, MD",{"name":106,"role":57,"phone":32,"phoneExt":32,"email":32},{"facility":109,"status":70,"city":110,"state":32,"zip":111,"country":73,"countryCode":74,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Institut Curie -site St Cloud","Saint-Cloud","92210",{"type":76,"coordinates":113},[114,115],2.20289,48.84598,{"lat":115,"lon":114},[118,120],{"name":119,"role":61,"phone":32,"phoneExt":32,"email":32},"Alexandre DE MOURA, MD",{"name":119,"role":57,"phone":32,"phoneExt":32,"email":32},{"facility":122,"status":70,"city":123,"state":32,"zip":124,"country":73,"countryCode":74,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"HIA Begin","Saint-Mandé","94160",{"type":76,"coordinates":126},[127,128],2.41579,48.83864,{"lat":128,"lon":127},[131,133],{"name":132,"role":61,"phone":32,"phoneExt":32,"email":32},"Hugo PICCHI, MD",{"name":132,"role":57,"phone":32,"phoneExt":32,"email":32},{"facility":135,"status":70,"city":136,"state":32,"zip":137,"country":73,"countryCode":74,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Hôpital FOCH","Suresnes","92150",{"type":76,"coordinates":139},[140,141],2.22929,48.87143,{"lat":141,"lon":140},[144,146],{"name":145,"role":61,"phone":32,"phoneExt":32,"email":32},"SEKKATE, MD",{"name":147,"role":57,"phone":32,"phoneExt":32,"email":32},"Sakina SEKKATE, MD",{"type":149,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100542949",false,"NCT06349512","68Ga-FAPI-46 PET\u002FCT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)","68Ga-FAPI-46 PET\u002FCT for Predicting Histological Response to Neoadjuvant Chemo-immunotherapy in Triple-negative Breast Cancer","FAP-IT","Inclusion Criteria:\n\n1. Female with age ≥ 18 years,\n2. Patients with previously untreated, non-metastatic, centrally confirmed TNBC for whom a neoadjuvant treatment with chemotherapy + pembrolizumab is the recommended option as standard of care,\n3. Patients with measurable targets according to RECIST\u002FPERCIST criteria,\n4. Patients without distant metastasis based on staging 18F-FDG PET\u002FCT,\n5. Patients with tumor tissue available,\n6. Patients who provided a signed written informed consent,\n7. Patient ability to comply with protocol requirements,\n8. Patients covered by a health insurance system.\n\nExclusion Criteria:\n\n1. Pregnant and lactating women,\n2. Patients with prior anti-PD(L)1 immunotherapy,\n3. Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment,\n4. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent,\n5. Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons,\n6. Person deprived of liberty or under guardianship","FEMALE","18 Years",{"count":160,"type":161},60,"ESTIMATED","INTERVENTIONAL",[34],[43],"2025-12-15",{"date":167,"type":168},"2025-12-22","ACTUAL",{"date":170,"type":168},"2024-10-14",{"date":172,"type":161},"2032-11-30",{"name":5,"class":6},6]