[68Ga]Ga-FAPI-46 in Staging of Head and Neck Carcinomas
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
| Condition(s) | Head and Neck Squamous Cell Carcinoma HNSCC |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * Age ≥18 years old * Karnofsky index ≥80% * Patients with operable head and neck cancer presenting histologically proven HNSCC (including Oral Cavity Cancer, Pharyngeal Cancer, Laryngeal Cancer) * Patients with at least one nodal metastasis * Patients scheduled for neck dissection * SOC imaging (MRI, ceCT and 18F-FDG-PET/CT) performed as pre-surgery exams * Written informed consent obtained Exclusion Criteria: * Known pregnancy or ongoing breast feeding * Claustrophobia * Severe renal insufficiency (GFR\<30 mL/min/1,73 m2) * Liver enzymes (ALAT, ASAT)\>5 times the standard upper limit * Bilirubin\>3 times the standard upper limit * Hemoglobin\<8 g/dL * Absolute neutrophil count\<1000/mm3 * Platelets\<75000/µL * insufficient knowledge of project language, inability to g |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | John O. Prior |
| Locations | Lausanne, Canton of Vaud, Switzerland |
| Start date | 2025-06-23 |
| NCT ID | NCT06794372 |
| Official listing | https://clinicaltrials.gov/study/NCT06794372 |