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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Netherlands
ZGT
NOT_YET_RECRUITING
Almelo
Amsterdam UMC
NOT_YET_RECRUITING
Amsterdam
Netherlands Cancer Institute - Antoni van Leeuwenhoek
NOT_YET_RECRUITING
Amsterdam
Rijnstate
NOT_YET_RECRUITING
Arnhem
Catharina Ziekenhuis
NOT_YET_RECRUITING
Eindhoven
Zuyderland
NOT_YET_RECRUITING
Geleen
UMC Groningen
NOT_YET_RECRUITING
Groningen
Leids Universitair Medisch Centrum
RECRUITING
Leiden
Erasmus MC
NOT_YET_RECRUITING
Rotterdam
UMC Utrecht
NOT_YET_RECRUITING
Utrecht
Contact Information
Primary
Sarah Spruijt, M.D.
s.w.j.m.spruijt@lumc.nl
+31 71 526 6029
Time Frame
Start Date: 2025-07-03
Estimated Completion Date: 2029-01
Participants
Target number of participants: 250
Treatments
Experimental: [18F]-FAPI-74 PET/CT
3.0 MBq \[18F\]-FAPI-74 will be administered intravenously 60 minutes before PET/CT scanning. Scanning time will be dependent on the type of scanner in the participating center, but will take approximately 20 minutes.
Related Therapeutic Areas
Sponsors
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov