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NCT Number: NCT06794372

[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 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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma HNSCC Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre hospitalier universitaire vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location status: Recruiting

Location contact

John O Prior, MD, PhD

CONTACT

[email protected]

+41 21 314 4348

Niklaus Schaefer, MD

PRINCIPAL_INVESTIGATOR

About this study

[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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[68Ga]Ga-FAPI-46 PET/CT

Drug

[68Ga]Ga-FAPI-46 PET/CT

Primary outcomes

  1. [68Ga]Ga-FAPI-46 PET/CT imaging results: tumor size

    Time frame: 6 weeks

    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).

  2. [68Ga]Ga-FAPI-46 PET/CT imaging results: tumor volume

    Time frame: 6 weeks

    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).

  3. [68Ga]Ga-FAPI-46 PET/CT imaging results: tumor SUVmax

    Time frame: 6 weeks

    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).

  4. [68Ga]Ga-FAPI-46 PET/CT imaging results: number of lesions

    Time frame: 6 weeks

    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).

  5. [68Ga]Ga-FAPI-46 PET/CT imaging results: lesion site

    Time frame: 6 weeks

    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).

  6. [68Ga]Ga-FAPI-46 PET/CT imaging results: lesion size

    Time frame: 6 weeks

    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).

  7. [68Ga]Ga-FAPI-46 PET/CT imaging results: lesion volume

    Time frame: 6 weeks

    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).

  8. [68Ga]Ga-FAPI-46 PET/CT imaging results: lesion SUVmax

    Time frame: 6 weeks

    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).

  9. [68Ga]Ga-FAPI-46 PET/CT imaging results: TNM tumor stage

    Time frame: 6 weeks

    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).

Secondary outcomes

  1. Ability of [68Ga]Ga-FAPI-46 PET/CT to visualize tumor infiltration in lymph nodes

    Time frame: 2 months

    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).

Other outcomes

  1. Evaluation of FAP+ CAFs distribution

    Time frame: 1 year

    Presence (positive/negative) of FAP+ cells in tumor center, tumor invasive margin and adjacent normal tissue.

  2. Comparison of [68Ga]Ga-FAPI-46 PET/CT with FAP immunoistochemistry

    Time frame: 1 year

    The ability of [68Ga]Ga-FAPI-46 PET/CT to identify FAP+ cells in lymph node lesions will be evaluated. The measurement will compare if lesions are defined as positive/negative by FAPI PET (positive/negative) and by histology showing FAP+ CAFs in the lesion.

  3. Evaluation of desmoplastic changes

    Time frame: 1 year

    Resected LNs will be analyzed by histopathology to determine the presence of desmoplastic changes. Desmoplastic changes will be expressed as the expression of specific molecular markers.

  4. Evaluation of modifications to the current therapeutic approach (questionnaire)

    Time frame: Questionnaire 2 ± 1 week after surgery

    Modifications to the current therapeutic approach will be evaluated by the head and neck surgeon, who will fill out a questionnaire about the foreseen therapeutic approach with and without taking into account the results of the [68Ga]Ga-FAPI-46 PET/CT. The questionnaire will contain yes/no questions or multiple choice questions.

Study contacts

Contact information is provided by the study sponsor or research team.

Assistant

CONTACT

+41 21 314 4347

John O Prior, MD, PhD

CONTACT

[email protected]

+41 21 314 4348

Sponsors and collaborators

Lead sponsor

John O. Prior

Other

Registry information

Official study title

[68Ga]Ga-FAPI-46 PET/CT in Early Detection of Lymph Node Metastasis in Head and Neck Squamous Cell Carcinomas

Acronym: FAPIHN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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