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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Leids Universitair Medisch Centrum
  Leiden, Netherlands Recruiting
• 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

Study contacts

• Study coordinator: Sarah Spruijt, M.D.
• Email: s.w.j.m.spruijt@lumc.nl
• Phone: +31 71 526 6029

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lenvatinib with nivolumab and chemotherapy for metastatic gastric cancer with malignant ascites

  This trial tests whether adding lenvatinib to nivolumab plus chemotherapy helps people with metastatic gastric or gastroesophageal junction adenocarcinoma who have peritoneal metastases and significant malignant ascites.

  Recruiting Phase 1/2 Asan Medical Center · Seoul · NCT07149090

• Total neoadjuvant chemotherapy for advanced gastric and gastroesophageal cancer

  This study is testing two different chemotherapy plans for people with advanced stomach cancer to see which one helps them better tolerate treatment and successfully have surgery.

  Recruiting at 2 sites Phase 2/3 Ukrainian Society of Clinical Oncology · Vilnius and 1 other locations · NCT06028737

• Rehabilitation and recovery program for esophageal and gastric cancer patients

  This study is testing a personalized rehabilitation program for people with esophageal and gastric cancer to see if it can improve their quality of life and help manage their symptoms.

  Recruiting Region Skane · Lund, Lund · NCT05698992

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• Neoadjuvant trastuzumab, durvalumab, and FLOT for HER2-positive gastric or GEJ cancer

  This study tests a pre-surgery treatment combining trastuzumab, durvalumab, and FLOT for patients with HER2-positive locally advanced gastric or gastroesophageal junction cancer to see how many achieve complete tumor disappearance.

  Recruiting Phase 2 Samsung Medical Center · Seoul, Gang-Nam · NCT07911280

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.