[68Ga]Ga-FAPI-46 in Staging of Head and Neck Carcinomas

Launched by JOHN O. PRIOR · Jan 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called \[68Ga\]Ga-FAPI-46 PET/CT to better understand and stage head and neck squamous cell carcinoma (HNSCC) before surgery. The goal is to see if this imaging can help identify lymph nodes that may be at risk of developing metastases, which is when cancer spreads from its original site. By targeting specific cells in the tumor environment that are linked to cancer spread, the researchers hope to improve how doctors can visualize and assess the extent of the disease, potentially leading to more personalized treatment plans.

To participate in this trial, you need to be at least 18 years old and have a diagnosis of operable head and neck cancer with at least one affected lymph node. You should also be scheduled for surgery to remove the cancer and have undergone standard imaging tests beforehand. Participants can expect to undergo the new imaging procedure, which will be compared with the results from their surgery to see how effective it is at identifying early signs of cancer spread. It's important to note that individuals with certain health conditions, such as severe kidney issues or those who are pregnant, are not eligible for this study. The trial is not yet recruiting, but it aims to provide valuable insights that could change how doctors approach treatment for patients with HNSCC.

Gender

ALL

Eligibility 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/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