68Ga-FAPI PET/CT: The Diagnostic Accuracy for Primary Staging and Re-staging after Chemotherapy in Patients with Gastric and Gastro-Esophageal Junctional Cancer

Phase 1

Recruiting

Conditions: Gastroesophageal junction cancer (GEJ-cancer), Gastric cancer
MedDRA version: 21.1Level: PTClassification code: 10017758Term: Gastric cancer Class: 100000004864
MedDRA version: 21.0Level: LLTClassification code: 10056267Term: Gastroesophageal cancer Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: CTIS2023-505916-40-01

Lead Sponsor: Aalborg University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 20

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, Fertile women (women of childbearing potential) not using effective contraceptives (definitions i protocol). 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, 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