18F-FAPI PET/CT and laparoscopy for staging advanced stomach cancer

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

This trial tests whether an 18F-FAPI PET/CT scan, used with laparoscopy, can better find spread of advanced stomach cancer and help doctors avoid unnecessary surgery.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Leiden University Medical Center (other)
• Drugs / interventions: radiation
• Locations: 10 sites (Almelo and 9 other locations)
• Trial ID: NCT07018661 on ClinicalTrials.gov

What this trial studies

Adults with surgically resectable advanced gastric adenocarcinoma undergo one additional [18F]FAPI-74 PET/CT scan (about 2 hours) alongside the standard imaging and diagnostic laparoscopy. The study records how often the FAPI-PET/CT detects metastases that change the treatment plan (for example avoiding curative surgery) or alter diagnostic steps (for example prompting additional biopsies or different surgical planning). It is a phase 2/3 interventional trial conducted at multiple centers in the Netherlands comparing FAPI-PET/CT findings with current standard care pathways. Outcomes include rates of management change and examination of whether the scan is less burdensome for patients than current methods.

Who should consider this trial

Good fit: Adults (≥18) with histologically proven, locally advanced, surgically resectable gastric adenocarcinoma or Siewert type III esophagogastric-junction tumors (cT3-4b, N0-3, M0) who are planned for gastrectomy and can undergo imaging and laparoscopy are ideal candidates.

Not a fit: Patients with Siewert type I–II tumors, known distant metastases, those unfit or unwilling to undergo surgery or the PET/CT, or pregnant patients are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the scan could identify hidden metastases earlier and reduce unnecessary surgeries, helping patients receive more appropriate curative or palliative care.

How similar studies have performed: Early clinical reports of FAPI PET imaging show promising high tumor contrast across cancers, but prospective multicenter data demonstrating changes in management for gastric cancer remain limited.

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).

Where this trial is running

Almelo and 9 other locations

• ZGT — Almelo, Netherlands (NOT_YET_RECRUITING)
• Amsterdam UMC — Amsterdam, Netherlands (NOT_YET_RECRUITING)
• Netherlands Cancer Institute - Antoni van Leeuwenhoek — Amsterdam, Netherlands (NOT_YET_RECRUITING)
• Rijnstate — Arnhem, Netherlands (NOT_YET_RECRUITING)
• Catharina Ziekenhuis — Eindhoven, Netherlands (NOT_YET_RECRUITING)
• Zuyderland — Geleen, Netherlands (NOT_YET_RECRUITING)
• UMC Groningen — Groningen, Netherlands (NOT_YET_RECRUITING)
• Leids Universitair Medisch Centrum — Leiden, Netherlands (RECRUITING)
• Erasmus MC — Rotterdam, Netherlands (NOT_YET_RECRUITING)
• UMC Utrecht — Utrecht, Netherlands (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Sarah Spruijt, M.D.

Conditions: Locally Advanced Gastric Adenocarcinoma, STOMACH NEOPLASM, Gastric Cancer, PET-CT, FAPI, 18F-FAPI-74, PET/CT, Imaging biomarker