NCT07018661 [18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer
| NCT ID | NCT07018661 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Leiden University Medical Center |
| Condition | Locally Advanced Gastric Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-07-03 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 250 participants in total. It began in 2025-07-03 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if a new type of scan, FAPI-PET/CT, can help find metastases of gastric cancer. We want to know how well this scan works for this purpose and whether it is less burdensome for patients compared to the methods we currently use to find metastases. The main questions it aims to answer are: * In how many patients can FAPI-PET/CT find metastases, which leads to a change in their treatment plan as decided by their medical team, such as avoiding unnecessary surgeries and changing from treatment meant to cure the disease to treatment focused on comfort (palliative treatment)? * In how many patients does FAPI-PET/CT change the diagnostic process as decided by their medical team, like more biopsies or imaging, or changing the type (extent) of surgery needed? Apart from the usual care gastric cancer patients receive, participants will: * Undergo one additional scan, which will take approximately 2 hours in total (excluding travel time) * Complete a number of questionnaires, which will take approximately 4 hours in total
Eligibility Criteria
Inclusion Criteria: * Histologically proven adenocarcinoma of the stomach or the esophagogastric junction (Siewert type III), by gastroscopy; * Age greater than or equal to 18 years; * Surgically resectable, advanced tumor (cT3-4b, N0-3, M0), as determined on gastroscopy and a contrast-enhanced CT of thorax and abdomen. Intention to perform a gastrectomy, based on a multidisciplinary team meeting and shared decision making; * Patients must have given written informed consent; * Patients who have recently participated in an interventional study with an investigational medicinal product (IMP) may only participate if an interaction with study procedures is deemed unlikely by the study team (e.g. based on mechanism or washout period). Exclusion Criteria: * Siewert type I-II esophagogastric junction tumor; * Unfit or unwilling to undergo study procedures; * Unfit or unwilling to undergo surgery; * Pregnancy at time of the \[18F\]AlF-FAPI-74 PET/CT scan, due to the investigational PET radiation burden; * Incapacitated subjects without decision-making capacity; * Medical or psychiatric conditions that compromise the patient's ability to give informed consent; * Illiterate patients unable to complete the resource use and quality of life questionnaires; * Inability to undergo PET/CT scans due to factors such as claustrophobia, weight limits, or the inability to lie flat for the duration of the scan (approximately 30 minutes).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07018661 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Gastric Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07018661 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07018661 currently recruiting?
Yes, NCT07018661 is actively recruiting participants. Contact the research team at s.w.j.m.spruijt@lumc.nl for enrollment information.
Where is the NCT07018661 trial being conducted?
This trial is being conducted at Almelo, Netherlands, Amsterdam, Netherlands, Amsterdam, Netherlands, Arnhem, Netherlands and 6 additional locations.
Who is sponsoring the NCT07018661 clinical trial?
NCT07018661 is sponsored by Leiden University Medical Center. The trial plans to enroll 250 participants.