NCT06794372 [68Ga]Ga-FAPI-46 in Staging of Head and Neck Carcinomas
| NCT ID | NCT06794372 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | John O. Prior |
| Condition | Head and Neck Squamous Cell Carcinoma HNSCC |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-23 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-06-23 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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. Employing \[68Ga\]Ga-FAPI-46 PET/CT 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. In this research endeavor, the primary objective is to highlight the additional value of \[68Ga\]Ga-FAPI-46 PET/CT 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/CT 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.
Eligibility Criteria
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 give consent or to follow trial-associated procedures * the patient makes use of his/her "right not to know" and refuses to be informed about incidental findings
Contact & Investigator
Niklaus Schaefer, MD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire Vaudois
Frequently Asked Questions
Who can join the NCT06794372 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma HNSCC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06794372 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06794372 currently recruiting?
Yes, NCT06794372 is actively recruiting participants. Contact the research team at john.prior@chuv.ch for enrollment information.
Where is the NCT06794372 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT06794372 clinical trial?
NCT06794372 is sponsored by John O. Prior. The principal investigator is Niklaus Schaefer, MD at Centre Hospitalier Universitaire Vaudois. The trial plans to enroll 20 participants.