NCT05898854CompletedPhase 2
[68Ga]Ga-FAPI PET/CT in Gastric and Gastroesophageal Junctional Cancer
[68Ga]Ga-FAPI PET/CT: The Dagnostic Accuracy for Primary Staging and Re-staging After Chemotherapy in Patients With Gastric and Gastro-esophageal Junctional Cancer
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 2 Jun 2023
- Start date
- 15 Feb 2024
- Primary completion date
- 18 Dec 2025
- Lead sponsor
- Aalborg University Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05898854
- EU CT number
- 2023-505916-40-01
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- From 15 Feb 2024 to the primary completion date, 18 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients with non-resectable, inoperable, or recurrent gastric or GEJ cancer
- History of allergic reactions / hypersensitivity attributed to 18F-FDG or 68Ga-FAPI-46.
- 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.
Lab values
- 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
- 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.
- 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).
Other
- Subject weighing more than 180 kg (weight limit scanner) or unable to fit within the imaging gantry
- Severe claustrophobia unresponsive to oral anxiolytics
- Pregnant, lactating, or breastfeeding women.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.