[68Ga]Ga-FAPI PET/CT in Gastric and Gastroesophageal Junctional Cancer

Launched by AALBORG UNIVERSITY HOSPITAL · Jun 2, 2023

Keywords

ClinConnect Summary

In this clinical trial, researchers are studying a special imaging test called FAPI PET/CT to see how well it works in diagnosing gastric cancer and gastro-esophageal junctional cancer compared to standard imaging methods. The goal is to find out if FAPI PET/CT can provide more accurate information about the cancer, which may help doctors make better decisions about treatment options for patients. The trial will involve 20 patients who have recently been diagnosed with these types of cancer and will undergo both FAPI PET/CT scans and regular imaging tests as part of their initial evaluation and follow-up.

To be eligible for this study, participants must be at least 18 years old, have a confirmed diagnosis of gastric or gastro-esophageal junctional cancer that can be surgically treated, and be able to understand and read Danish. Participants should not have other types of cancer, or conditions that would prevent them from completing the study, such as severe anxiety about enclosed spaces (claustrophobia) or certain medical issues. During the study, participants can expect to receive both types of imaging tests, and their results will help researchers understand the benefits of using FAPI PET/CT in cancer management. Overall, this research aims to improve how we diagnose and treat these cancers, ultimately helping patients receive better care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Newly diagnosed with biopsy verified gastric or GEJ cancer and referred to primary staging FDG PET/CT
• • Deemed resectable and operable at the MDT, with or without neoadjuvant chemotherapy
• • Considered physically and mentally able to participate in the research project
• • Can read and understand Danish
• • 18-years or older and able to consent to project participation
• Exclusion Criteria:
• • Patients with non-resectable, inoperable, or recurrent gastric or GEJ cancer
• • Patients with an imminent need for surgery or in an emergency
• • Known concurrent other malignancy within the previous 5 years other than non-melanoma skin cancer
• • Patients not suited for surgery or neoadjuvant chemotherapy followed by surgery
• • Subject weighing more than 180 kg (weight limit scanner) or unable to fit within the imaging gantry
• • History of allergic reactions / hypersensitivity attributed to 18F-FDG or 68Ga-FAPI-46.
• • Severe claustrophobia unresponsive to oral anxiolytics
• • Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study.
• • Pregnant, lactating, or breastfeeding women.
• • Potential pregnant women of childbearing potential\[1\] not using effective contraceptives\[2\]. Potential pregnancy will be ascertained by a pregnancy test (urine humane choriogonadotropin (HCG) or serum HCG) \< 48 hours before injection with 68Ga-FAPI-46.
• • Inability to remain still for the duration of the examination
• • 1. Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, i.e., not sterilized (bilateral tubectomy/occlusion, hysterectomy, bilateral oophorectomy) and not post-menopausal. In cases of uncertain menopausal status, serum follicle stimulating hormone (FSH) levels and menstruation history can be assessed.
• • 2. Effective contraceptives include sexual abstinence, vasectomized partner, combined hormonal contraception (oral, intravaginal, transdermal), progesterone-only contraceptive (oral, injectable, implantable), or working intrauterine device (hormonal, non-hormonal).