CTIS2023-505916-40-01RecruitingPhase 1
68Ga-FAPI PET/CT: The Diagnostic Accuracy for Primary Staging and Re-staging after Chemotherapy in Patients with Gastric and Gastro-esophageal Junctional Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Aalborg University Hospital
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
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
Investigators
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