68Ga-FAPI-46 PET/CT in the Early Detection of Lymph Node Metastases from Head and Neck Squamous Cell Carcinomas
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
Pregnancy and breastfeeding. Abnormal blood test results. Claustrophobia. (BASEC)
Studienstandort
Lausanne
(BASEC)
Sponsor
Lausanne University Hospital – CHUV Represented by Prof. J. Prior – Head of Department of Nuclear Medicine and Molecular Imaging
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Niklaus Schaefer
+41213173337
Niklaus.Schaefer@clutterchuv.chCentre Hospitalier Universitaire Vaudois (CHUV)
(BASEC)
Allgemeine Auskünfte
Centre Hospitalier Universitaire Vaudois,
+41 21 314 4348;+41 21 314 4348
Niklaus.Schaefer@clutterchuv.ch(ICTRP)
Allgemeine Auskünfte
Centre Hospitalier Universitaire Vaudois
+41 21 314 4348+41 21 314 4348
Niklaus.Schaefer@clutterchuv.ch(ICTRP)
Wissenschaftliche Auskünfte
Centre Hospitalier Universitaire Vaudois,
+41 21 314 4348;+41 21 314 4348
Niklaus.Schaefer@clutterchuv.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
18.11.2024
(BASEC)
ICTRP Studien-ID
NCT06794372 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
68Ga-FAPI-46 in staging of head and neck carcinoma (BASEC)
Wissenschaftlicher Titel
[68Ga]Ga-FAPI-46 PET/CT in Early Detection of Lymph Node Metastasis in Head and Neck Squamous Cell Carcinomas (ICTRP)
Öffentlicher Titel
[68Ga]Ga-FAPI-46 in Staging of Head and Neck Carcinomas (ICTRP)
Untersuchte Krankheit(en)
Head and Neck Squamous Cell Carcinoma HNSCC (ICTRP)
Untersuchte Intervention
Drug: [68Ga]Ga-FAPI-46 PET/CT (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
[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)
Registrierungsdatum
24.12.2024 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
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)
Sekundäre IDs
2024-01881, FAPIHN (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06794372 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar