Head and Neck Squamous Cell Carcinoma HNSCCPhase 2FAPIHNNCT06794372
[68Ga]Ga-FAPI-46 in Staging of Head and Neck Carcinomas
A Phase 2 study testing [68Ga]Ga-FAPI-46 PET/CT in people with Head and Neck Squamous Cell Carcinoma HNSCC, run by John O. Prior at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma HNSCC
- What is being tested?
- [68Ga]Ga-FAPI-46 PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Jun 2025to Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Assistant contact
Switzerland1 site, 1 recruiting
- Recruiting
Centre hospitalier universitaire vaudois
Lausanne, Canton of Vaud, 1011
John O Prior, MD, PhD, +41 21 314 4348, john.prior@chuv.ch
Niklaus Schaefer, MD
About this study
Official title: [68Ga]Ga-FAPI-46 PET/CT in Early Detection of Lymph Node Metastasis in Head and Neck Squamous Cell 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 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.
Read the detailed description
[68Ga]Ga-FAPI-46 PET/CT is an advanced imaging technique utilized in nuclear medicine for the evaluation of various cancers. The imaging agent [68Ga]Ga-FAPI-46 specifically targets FAP, a protein overexpressed by CAFs in the tumor microenvironment. This targeted approach allows for precise visualization of FAP-positive tumors, aiding in the detection, staging, and assessment of therapeutic response. The integration of PET and CT modalities provides both functional and anatomical information, enhancing the accuracy of the imaging results. In this study, the investigators will specifically evaluate the application of [68Ga]Ga-FAPI-46 PET/CT in patients diagnosed with HNSCC who are scheduled for primary clinical resection. This research aims to explore the potential of [68Ga]Ga-FAPI-46 PET/CT in guiding treatment decisions and optimizing the management of HNSCC, contributing valuable insights to the growing knowledge in precision oncology.
Patients with confirmed HNSCC and planned to undergo tumor and LN dissection surgery will be recruited for this project. The included patients will follow their standard-of-care clinical investigations according to current guideline-based recommendations.
Patients will receive [68Ga]Ga-FAPI-46 in a dose of 2MBq/kg (+/-15%) as an IV injection. The total administered dose will be between 80 and 200MBq. 60 minutes (+/- 10min) after the injection, low-dose, non-contrast-enhanced PET/CT will be acquired for about 20 minutes.
- Being tested
- [68Ga]Ga-FAPI-46 PET/CT
- Keywords
- Head and Neck Squamous Cell Carcinoma, Cancer-associated fibroblasts, PET/CT, Lymph nodes, Tumor microenvironment, Fibroblast activation protein
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-FAPI-46 PET/CTDrug
[68Ga]Ga-FAPI-46 PET/CT
| Study group | Role | What they receive |
|---|---|---|
| HNSCC patients | Experimental | Patients with operable head and neck cancer presenting histologically proven HNSCC, planned to undergo surgery (tumour and lymph node dissection), and who will benefit, as standard of care, from cervical MRI, ceCT and 18F-FDG PET/CT. Receives: Drug: [68Ga]Ga-FAPI-46 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
[68Ga]Ga-FAPI-46 PET/CT imaging results: tumor size
The tumor size (mm*mm) measured by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: tumor volume
The tumor volume (mm^3) measured by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: tumor SUVmax
The SUVmax of the tumor measured by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: number of lesions
The number of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported.
Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion site
The site of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported.
Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion size
The size (mm*mm) of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported.
Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion volume
The volume (mm^3) of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported.
Results will be compared to the clinically indicated standard imaging (FDG PET/CT).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion SUVmax
The SUVmax of lesions (for nearby lymph nodes and distant metastases) visible by 68Ga-FAPI-46 PET/CT will be reported.
Results will be compared to the clinically indicated standard imaging (FDG PET/CT).
Measured: 6 weeks
[68Ga]Ga-FAPI-46 PET/CT imaging results: TNM tumor stage
The TNM stage calculated by 68Ga-FAPI-46 PET/CT will be reported. Results will be compared to the clinically indicated standard imaging (FDG PET/CT, ceCT and MRI).
Measured: 6 weeks
Secondary outcomes (1)
Ability of [68Ga]Ga-FAPI-46 PET/CT to visualize tumor infiltration in lymph nodes
Histopathology of clinically indicated resected lymph node specimen will be performed. [68Ga]Ga-FAPI-46 PET/CT results and tumor infiltration findings by histology will be compared (lesions defined positive/negative as a result of the two techniques).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start23 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma HNSCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John O. Prior
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John O. Prior, University of Lausanne Hospitals
- Investigators
- Niklaus Schaefer, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794372
- Sponsor's protocol ID
- FAPIHN
- Other IDs
- 2024-01881
- Acronym
- FAPIHN
- Status last verified
- May 2026
- First submitted
- 24 Dec 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No