RecruitingPhase 2Phase 3NCT07018661

[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


Sponsor

Leiden University Medical Center

Enrollment

250 participants

Start Date

Jul 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new type of PET scan (using a tracer called [18F]F-FAPI) combined with a small camera procedure inside the belly (laparoscopy) to more accurately determine how far advanced stomach cancer has spread before surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stomach cancer or a certain type of cancer where the stomach meets the esophagus (Siewert type III), confirmed by biopsy - Your cancer is considered surgically removable (stage cT3-4b) and a surgical team plans to perform a gastrectomy (stomach removal) **You may NOT be eligible if...** - Your tumor is a different type of esophagus-stomach junction cancer (Siewert type I or II) - You are unable or unwilling to undergo surgery or study procedures - You are pregnant at the time of the PET scan - You cannot have a PET/CT scan due to claustrophobia, weight limits, or inability to lie still for ~30 minutes - You lack the mental capacity to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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)

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

View Full Details on ClinicalTrials.gov

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NCT07018661


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