[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"John O. Prior\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100577136","phase-2-68gaga-fapi-46-in-staging-of-head-and-neck-carcinomas-100577136",false,"NCT06794372","[68Ga]Ga-FAPI-46 in Staging of Head and Neck Carcinomas","[68Ga]Ga-FAPI-46 PET\u002FCT in Early Detection of Lymph Node Metastasis in Head and Neck Squamous Cell Carcinomas","FAPIHN","Inclusion Criteria:\n\n* Age ≥18 years old\n* Karnofsky index ≥80%\n* Patients with operable head and neck cancer presenting histologically proven HNSCC (including Oral Cavity Cancer, Pharyngeal Cancer, Laryngeal Cancer)\n* Patients with at least one nodal metastasis\n* Patients scheduled for neck dissection\n* SOC imaging (MRI, ceCT and 18F-FDG-PET\u002FCT) performed as pre-surgery exams\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Known pregnancy or ongoing breast feeding\n* Claustrophobia\n* Severe renal insufficiency (GFR\\\u003C30 mL\u002Fmin\u002F1,73 m2)\n* Liver enzymes (ALAT, ASAT)\\>5 times the standard upper limit\n* Bilirubin\\>3 times the standard upper limit\n* Hemoglobin\\\u003C8 g\u002FdL\n* Absolute neutrophil count\\\u003C1000\u002Fmm3\n* Platelets\\\u003C75000\u002FµL\n* insufficient knowledge of project language, inability to give consent or to follow trial-associated procedures\n* the patient makes use of his\u002Fher \"right not to know\" and refuses to be informed about incidental findings","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The trial focuses on assessing the role of \\[68Ga\\]Ga-FAPI-46 in head and neck squamous cell carcinomas (HNSCC) staging before surgery. In the context of metastasis, cancer-associated fibroblasts (CAFs) emerge as pivotal contributors to the creation of a microenvironment conducive to future metastases. CAFs exert their influence through intricate mechanisms, including the remodeling of the extracellular matrix by secreting proteins such as collagen and fibronectin. This process enhances the structural support for cancer cell invasion into adjacent tissues. Additionally, CAFs play a central role in promoting angiogenesis, ensuring an adequate blood supply to the tumor, which may also facilitate the entry of cancer cells into the bloodstream. Through modulation of immune responses within the tumor microenvironment, CAFs establish an immunosuppressive milieu, providing a permissive environment for cancer cell survival and dissemination. Collectively, the orchestrated activities of CAFs contribute to the preparation of a metastatic niche, influencing the microenvironment at both primary and secondary sites and enhancing the likelihood of successful metastasis.\n\nEmploying \\[68Ga\\]Ga-FAPI-46 PET\u002FCT imaging to target activated CAFs may hold the potential to discern lymph nodes (LNs) predisposed to future metastases in HNSCC. The use of this imaging modality offers a unique opportunity to visualize and assess the presence and activity of CAFs within the tumor microenvironment. By targeting the fibroblast activation protein (FAP), a receptor enriched on CAFs, this imaging approach provides a specific and sensitive mean to identify regions where the microenvironment may favor metastatic progression.\n\nIn this research endeavor, the primary objective is to highlight the additional value of \\[68Ga\\]Ga-FAPI-46 PET\u002FCT into the standard pre-surgical imaging protocol. Additionally, the study will evaluate the efficacy of FAP positon emission tomography (PET) in primary tumor delineation. Imaging based on \\[68Ga\\]Ga-FAPI-46 allows the identification of CAFs, specifically by exploiting their increased FAP expression. The study aims also to systematically compare the \\[68Ga\\]Ga-FAPI-46 PET\u002FCT signals with the characteristics of resected lymph nodes, seeking to ascertain the capability of FAPI PET imaging in identifying premetastatic conditions. By comparing the \\[68Ga\\]Ga-FAPI-46 PET signal and the histopathological features of resected lymph nodes, the goal is to validate the potential of \\[68Ga\\]Ga-FAPI-46 PET imaging as a tool for early detection of premalignant or metastatic conditions in the lymphatic system before surgical intervention. The ability to pinpoint lymph nodes at risk for future metastases could revolutionize clinical decision-making, by facilitating a more nuanced understanding of disease spread, thereby informing personalized treatment strategies and potentially improving patient outcomes.",[27],"Head and Neck Squamous Cell Carcinoma HNSCC",[29,30,31,32,33,34],"Head and Neck Squamous Cell Carcinoma","Cancer-associated fibroblasts","PET\u002FCT","Lymph nodes","Tumor microenvironment","Fibroblast activation protein","RECRUITING","2026-05-05",{"date":38,"type":39},"2026-05-06","ACTUAL",{"date":41,"type":39},"2025-06-23",{"date":43,"type":21},"2026-12",{"name":45,"class":46},"John O. Prior","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100477643","phase-2-68gaga-pentixafor-petct-in-acute-myocardial-inflammation-100477643","NCT05499637","[68Ga]Ga-PentixaFor PET\u002FCT in Acute Myocardial Inflammation","Pilot Study to Evaluate the Accuracy of [68Ga]Ga-PentixaFor PET\u002FCT in the Diagnosis of Three Clinical Entities of Acute Myocardial Inflammation","Inclusion Criteria:\n\n* signed written informed consent\n* male or female\n* age ≥ 18 years\n* patients with suspicion CS (group II) or ICIM (group III) or in their regular follow-up in their first year after HT (group I)\n* SOC clinical follow-up at the cardiology department in CHUV.\n\nExclusion Criteria:\n\nThe presence of any one of the following exclusion criteria will lead to exclusion of the participant:\n\n* absence of a signed written informed consent\n* patients aged \\\u003C 18 years\n* claustrophobia\n* myocardial ischemia in non-invasive perfusion test or coronarography in group II and III\n* clinically unstable cardiovascular conditions, including:\n\n  * clinically unstable brady-tachyarrhythmia\n  * severe and symptomatic hypo- or hypertension with documented systolic blood pressure \\\u003C 90 mmHg or ≥220 mmHg respectively\n  * cardiogenic shock.\n* women who are pregnant or breast feeding\n* intention to become pregnant during the course of the study in group II\n* previous enrolment into the current study\n* moderate to severe renal insufficiency (GFR \\\u003C 45 mL\u002Fmin\u002F1,73 m2), with contra-indication to the administration of Gadolinium in group II and III\n* enrollment of the investigator, his\u002Fher family members, employees and other dependent persons\n* history of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment\n* insufficient knowledge of project language, inability to give consent or to follow procedures\n* the patient makes use of his\u002Fher \"right not to know\" and refuses to be informed about incidental findings",{"count":56,"type":21},69,[24],"Acute myocardial inflammation is an heterogenic syndrome involving different clinical pathologies with different outcome. For the purpose of this study protocol, we focuse on three entities of this syndrome, namely the acute cellular cardiac allograft rejection (ACR), cardiac sarcoidosis (CS) and the immune checkpoint inhibitor induced myocarditis (ICIM), for which non-invasive diagnosis remains challenging.\n\nSince accurate diagnosis of myocardial inflammation in an early stage is crucial, this study aims to investigate the accuracy of \\[68Ga\\]Ga-PentixaFor as a marker of for the presence of inflammatory cells (T-lymphocytes and M1) in described patients.\n\nThe identification of a correlation between \\[68Ga\\]Ga-PentixaFor myocardial accumulation with currently accepted diagnostic tools would open up new ways to non-invasively diagnose acute myocardial inflammation.",[60,61,62],"Acute Cellular Graft Rejection","Cardiac Sarcoidosis","Myocarditis Due to Drug",{"date":64,"type":39},"2026-05-11",{"date":66,"type":39},"2023-01-17",{"date":68,"type":21},"2027-01",{"name":45,"class":46},""]