Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer

[18F]F-FAPI PET/CT and LAparoscopy in STagIng Advanced Gastric Cancer - a Multicenter Prospective Study

[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer (NCT07018661) is a Phase 2 / Phase 3 interventional studying Locally Advanced Gastric Adenocarcinoma and STOMACH NEOPLASM, sponsored by Leiden University Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Locally Advanced Gastric Adenocarcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 250 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Locally Advanced Gastric Adenocarcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form; - 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 waiting period after previous treatment). Who Should NOT Join This Trial: - 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 willing to sign a consent form; - 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). Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

DIAGNOSTIC_TEST

[18F]FAPI-74 PET/CT

Patients included in the study will undergo FAPI-PET/CT after initial staging with gastroscopy and a contrast-enhanced CT of thorax and abdomen, but before undergoing a staging laparoscopy. Based on the results of the FAPI-PET/CT, the MDT and/or treating physician will decide on the next step: confirming possible malignant lesions on PET/CT by biopsies (either percutaneous of by staging laparoscopy), or in case of negative PET/CT, diagnostic laparoscopy.

DRUG

[18F]-FAPI-74

\[18F\]-FAPI-74 will be administered intravenously 60 minutes before PET/CT-scanning to be able to detect (metastases of) gastric cancer

Locations (10)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

ZGT

Almelo, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, Netherlands

Rijnstate

Arnhem, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Zuyderland

Geleen, Netherlands

UMC Groningen

Groningen, Netherlands

Leids Universitair Medisch Centrum

Leiden, Netherlands

Erasmus MC

Rotterdam, Netherlands

UMC Utrecht

Utrecht, Netherlands

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07018661), the sponsor (Leiden University Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07018661 clinical trial studying?

Who can participate in NCT07018661?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07018661?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT07018661. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07018661. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.