68Ga-FAPI-46 PET/CT in the Early Detection of Lymph Node Metastases from Head and Neck Squamous Cell Carcinomas
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
Pregnancy and breastfeeding. Abnormal blood test results. Claustrophobia. (BASEC)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
Lausanne University Hospital – CHUV Represented by Prof. J. Prior – Head of Department of Nuclear Medicine and Molecular Imaging
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Niklaus Schaefer
+41213173337
Niklaus.Schaefer@clutterchuv.chCentre Hospitalier Universitaire Vaudois (CHUV)
(BASEC)
Informations générales
Centre Hospitalier Universitaire Vaudois,
+41 21 314 4348;+41 21 314 4348
Niklaus.Schaefer@clutterchuv.ch(ICTRP)
Informations générales
Centre Hospitalier Universitaire Vaudois
+41 21 314 4348+41 21 314 4348
Niklaus.Schaefer@clutterchuv.ch(ICTRP)
Informations scientifiques
Centre Hospitalier Universitaire Vaudois,
+41 21 314 4348;+41 21 314 4348
Niklaus.Schaefer@clutterchuv.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
18.11.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT06794372 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
68Ga-FAPI-46 in staging of head and neck carcinoma (BASEC)
Titre académique
[68Ga]Ga-FAPI-46 PET/CT in Early Detection of Lymph Node Metastasis in Head and Neck Squamous Cell Carcinomas (ICTRP)
Titre public
[68Ga]Ga-FAPI-46 in Staging of Head and Neck Carcinomas (ICTRP)
Maladie en cours d'investigation
Head and Neck Squamous Cell Carcinoma HNSCC (ICTRP)
Intervention étudiée
Drug: [68Ga]Ga-FAPI-46 PET/CT (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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)
non disponible
Critères d'évaluation principaux et secondaires
[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)
Date d'enregistrement
24.12.2024 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
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)
ID secondaires
2024-01881, FAPIHN (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06794372 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible