[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of scan called FAPI-PET/CT to see if it can better detect the spread of advanced gastric cancer, also known as stomach cancer. The goal is to find out how effective this scan is in identifying metastases, which are areas where the cancer has spread to other parts of the body. Researchers want to see if using this scan can help doctors change treatment plans for patients, potentially avoiding unnecessary surgeries or switching to treatments that focus on comfort rather than curing the disease.

To participate in this study, individuals must be at least 18 years old and have a specific type of stomach cancer that can still be surgically removed. Participants will receive the FAPI-PET/CT scan and complete some questionnaires, which will take a few hours in total. It's important to note that the trial is not yet recruiting participants, and those interested should discuss their eligibility and any questions with their healthcare team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically proven adenocarcinoma of the stomach or the esophagogastric junction (Siewert type III), by gastroscopy;
• • Age greater than or equal to 18 years;
• • Surgically resectable, advanced tumor (cT3-4b, N0-3, M0), as determined on gastroscopy and a contrast-enhanced CT of thorax and abdomen. Intention to perform a gastrectomy, based on a multidisciplinary team meeting and shared decision making;
• • Patients must have given written informed consent;
• • Patients who have recently participated in an interventional study with an investigational medicinal product (IMP) may only participate if an interaction with study procedures is deemed unlikely by the study team (e.g. based on mechanism or washout period).
• Exclusion Criteria:
• • Siewert type I-II esophagogastric junction tumor;
• • Unfit or unwilling to undergo study procedures;
• • Unfit or unwilling to undergo surgery;
• • Pregnancy at time of the \[18F\]AlF-FAPI-74 PET/CT scan, due to the investigational PET radiation burden;
• • Incapacitated subjects without decision-making capacity;
• • Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
• • Illiterate patients unable to complete the resource use and quality of life questionnaires;
• • Inability to undergo PET/CT scans due to factors such as claustrophobia, weight limits, or the inability to lie flat for the duration of the scan (approximately 30 minutes).