68Ga-FAPI-46 PET/CT in the Early Detection of Lymph Node Metastases from Head and Neck Squamous Cell Carcinomas
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
Pregnancy and breastfeeding. Abnormal blood test results. Claustrophobia. (BASEC)
Luogo dello studio
Losanna
(BASEC)
Sponsor
Lausanne University Hospital – CHUV Represented by Prof. J. Prior – Head of Department of Nuclear Medicine and Molecular Imaging
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Niklaus Schaefer
+41213173337
Niklaus.Schaefer@clutterchuv.chCentre Hospitalier Universitaire Vaudois (CHUV)
(BASEC)
Informazioni generali
Centre Hospitalier Universitaire Vaudois,
+41 21 314 4348;+41 21 314 4348
Niklaus.Schaefer@clutterchuv.ch(ICTRP)
Informazioni generali
Centre Hospitalier Universitaire Vaudois
+41 21 314 4348+41 21 314 4348
Niklaus.Schaefer@clutterchuv.ch(ICTRP)
Informazioni scientifiche
Centre Hospitalier Universitaire Vaudois,
+41 21 314 4348;+41 21 314 4348
Niklaus.Schaefer@clutterchuv.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
18.11.2024
(BASEC)
ID di studio ICTRP
NCT06794372 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
68Ga-FAPI-46 in staging of head and neck carcinoma (BASEC)
Titolo accademico
[68Ga]Ga-FAPI-46 PET/CT in Early Detection of Lymph Node Metastasis in Head and Neck Squamous Cell Carcinomas (ICTRP)
Titolo pubblico
[68Ga]Ga-FAPI-46 in Staging of Head and Neck Carcinomas (ICTRP)
Malattie studiate
Head and Neck Squamous Cell Carcinoma HNSCC (ICTRP)
Intervento studiato
Drug: [68Ga]Ga-FAPI-46 PET/CT (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
[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)
Data di registrazione
24.12.2024 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
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 secondari
2024-01881, FAPIHN (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06794372 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile