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

NCT07018661 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-08-27

No results posted yet for this study

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

Conditions

  • Locally Advanced Gastric Adenocarcinoma
  • STOMACH NEOPLASM
  • Gastric Cancer
  • PET-CT

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

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-03
Primary Completion
2028-01-31
Completion
2029-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07018661 on ClinicalTrials.gov