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RECRUITING
NCT07018661
PHASE2/PHASE3

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

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2025-07-03

Completion Date

2029-01

Last Updated

2025-08-27

Healthy Volunteers

No

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