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68Ga-FAPI PET/CT: The Diagnostic Accuracy for Primary Staging and Re-staging after Chemotherapy in Patients with Gastric and Gastro-Esophageal Junctional Cancer
EU CTIS ID: 2023-505916-40-01
What this study is testing
1. Compare the diagnostic accuracy of FAPI PET/CT to FDG PET/CT on a lesion basis at primary staging and restaging (after neoadjuvant chemotherapy) 2. Compare the FAPI PET/CT to FDG PET/CT tentative staging at primary staging and restaging (after neoadjuvant chemotherapy) 3. Investigate the feasibility of FAPI PET/CT at restaging (after chemotherapy) 4. Explore the potential limitations of FAPI PET/CT in tumor deposits
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.