68Ga-FAPI-46 PET/CT in the Early Detection of Lymph Node Metastases from Head and Neck Squamous Cell Carcinomas
Summary description of the study
Head and neck squamous cell carcinomas require a multidisciplinary approach. Before surgery, patients undergo a series of diagnostic procedures, including imaging studies such as CT scans, MRI, and 18F-FDG PET/CT (positron emission tomography using the radioactive isotope 18F-FDG). The planning of tumor resection, especially the extent of resection, is based on imaging results. In this study, we examine how 68Ga-FAPI-46 PET/CT imaging can assist in the diagnostic process and treatment of head and neck carcinomas to improve the detection of metastases and lymph nodes affected by the tumor.
(BASEC)
Intervention under investigation
The intervention evaluated in this study is the PET/CT imaging with ⁶⁸Ga-FAPI-46, a molecular imaging technique targeting the fibroblast activation protein (FAP), expressed by cancer-associated fibroblasts (CAFs) in the tumor microenvironment. The ⁶⁸Ga-FAPI-46 tracer is used to visualize activated CAFs in patients with head and neck squamous cell carcinoma (HNSCC). The aim of the study is to assess the added value of this imaging modality for preoperative staging, delineation of the primary tumor, as well as for early detection of lymph nodes at risk of metastasis.
(BASEC)
Disease under investigation
head and neck squamous cell carcinomas
(BASEC)
Patients >18 years old. Patients with head and neck squamous cell carcinomas for which tumor resection is planned. Patients who have already undergone standard imaging performed routinely (FDG PET/CT, MRI, and CT imaging with contrast injection). (BASEC)
Exclusion criteria
Pregnancy and breastfeeding. Abnormal blood test results. Claustrophobia. (BASEC)
Trial sites
Lausanne
(BASEC)
Sponsor
Lausanne University Hospital – CHUV Represented by Prof. J. Prior – Head of Department of Nuclear Medicine and Molecular Imaging
(BASEC)
Contact
Contact Person Switzerland
Niklaus Schaefer
+41213173337
Niklaus.Schaefer@clutterchuv.chCentre Hospitalier Universitaire Vaudois (CHUV)
(BASEC)
General Information
Centre Hospitalier Universitaire Vaudois,
+41 21 314 4348;+41 21 314 4348
john.prior@chuv.ch(ICTRP)
General Information
Centre Hospitalier Universitaire Vaudois
+41 21 314 4348+41 21 314 4348
john.prior@chuv.chjohn.prior@chuv.ch(ICTRP)
Scientific Information
Centre Hospitalier Universitaire Vaudois,
+41 21 314 4348;+41 21 314 4348
john.prior@chuv.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
18.11.2024
(BASEC)
ICTRP Trial ID
NCT06794372 (ICTRP)
Official title (approved by ethics committee)
68Ga-FAPI-46 in staging of head and neck carcinoma (BASEC)
Academic title
[68Ga]Ga-FAPI-46 PET/CT in Early Detection of Lymph Node Metastasis in Head and Neck Squamous Cell Carcinomas (ICTRP)
Public title
[68Ga]Ga-FAPI-46 in Staging of Head and Neck Carcinomas (ICTRP)
Disease under investigation
Head and Neck Squamous Cell Carcinoma HNSCC (ICTRP)
Intervention under investigation
Drug: [68Ga]Ga-FAPI-46 PET/CT (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion 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/L
- 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 (ICTRP)
not available
Primary and secondary end points
[68Ga]Ga-FAPI-46 PET/CT imaging results: tumor size;[68Ga]Ga-FAPI-46 PET/CT imaging results: tumor volume;[68Ga]Ga-FAPI-46 PET/CT imaging results: tumor SUVmax;[68Ga]Ga-FAPI-46 PET/CT imaging results: number of lesions;[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion site;[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion size;[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion volume;[68Ga]Ga-FAPI-46 PET/CT imaging results: lesion SUVmax;[68Ga]Ga-FAPI-46 PET/CT imaging results: TNM tumor stage (ICTRP)
Ability of [68Ga]Ga-FAPI-46 PET/CT to visualize tumor infiltration in lymph nodes (ICTRP)
Registration date
24.12.2024 (ICTRP)
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Niklaus Schaefer, MD;John O Prior, MD, PhD;John O Prior, MD, PhD, john.prior@chuv.ch, +41 21 314 4348;+41 21 314 4348, Centre Hospitalier Universitaire Vaudois, (ICTRP)
Secondary trial IDs
2024-01881, FAPIHN (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT06794372 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available