TheranosticTrials.org

Clinical Trial · NCT05898854

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

Overview

Twenty (n=20) patients with gastric cancer or gastro-esophageal junctional cancer will undergo FAPI PET/CTs in addition to routing diagnostic workup (including FDG PET/CT) at primary staging and restaging. The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT) using histopathology as reference standard, and the diagnostic accuracy will be determined. FAP-immunohistochemistry will be conducted in surgical specimens. FAPI PET/CT's impact on patient management and the prognostic value of FAPI PET/CT will be evaluated.

Sponsor

Aalborg University Hospital

Phase

Phase 2

ClinicalTrials.gov

NCT05898854

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

FAPI-46

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Can read and understand Danish
  • Newly diagnosed with biopsy verified gastric or GEJ cancer and referred to primary staging FDG PET/CT
  • Considered physically and mentally able to participate in the research project
  • Deemed resectable and operable at the MDT, with or without neoadjuvant chemotherapy

Exclusion

  • History of allergic reactions / hypersensitivity attributed to 18F-FDG or 68Ga-FAPI-46.
  • 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.
  • Pregnant, lactating, or breastfeeding women.
  • Inability to remain still for the duration of the examination
  • Patients with an imminent need for surgery or in an emergency
  • Subject weighing more than 180 kg (weight limit scanner) or unable to fit within the imaging gantry
  • 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.
  • Severe claustrophobia unresponsive to oral anxiolytics
  • 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).
  • 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.
  • Patients with non-resectable, inoperable, or recurrent gastric or GEJ cancer
  • Patients not suited for surgery or neoadjuvant chemotherapy followed by surgery