[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer
PLASTIC-3
[18F]F-FAPI PET/CT and LAparoscopy in STagIng Advanced Gastric Cancer - a Multicenter Prospective Study
2 other identifiers
interventional
250
1 country
10
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2025
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2025
CompletedFirst Posted
Study publicly available on registry
June 12, 2025
CompletedStudy Start
First participant enrolled
July 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
August 27, 2025
August 1, 2025
2.5 years
April 4, 2025
August 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in treatment intent
Proportion of patients in whom \[18F\]AlF-FAPI-74 PET/CT leads to detection of M1-disease resulting in change in treatment intent determined by the local multidisciplinary team (MDT) meetings, including: * The number of prevented unnecessary surgeries (staging laparoscopies and/or gastrectomies) * The number of changes from curative to palliative treatment
For each patient from enrollment through study completion, an average of 1 year.
Change in diagnostic work-up
Proportion of patients in whom \[18F\]AlF-FAPI-74 PET/CT leads to changes in diagnostic work-up determined by the local MDT meetings, including: * The number of additional biopsies or longitudinal imaging * The number of changes in extent of surgery
Immediately after completion of clinical staging. Clinical staging consists of FAPI-PET/CT, additional diagnostics following FAPI-PET/CT (if necessary to confirm suspect lesions on FAPI-PET/CT) and/or diagnostic laparoscopy
Secondary Outcomes (16)
Diagnostic performance
Immediately after completion of clinical staging. Clinical staging consists of FAPI-PET/CT, additional diagnostics following FAPI-PET/CT (if necessary to confirm suspect lesions on FAPI-PET/CT) and/or diagnostic laparoscopy
Incidental findings
Immediately after completion of clinical staging. Clinical staging consists of FAPI-PET/CT, additional diagnostics following FAPI-PET/CT (if necessary to confirm suspect lesions on FAPI-PET/CT) and/or diagnostic laparoscopy
Impact of incidental and/or non-specific findings
At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months]
Impact of incidental and/or non-specific findings
At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months]
Impact of incidental and/or non-specific findings
Immediately after completion of clinical staging. Clinical staging consists of FAPI-PET/CT, additional diagnostics following FAPI-PET/CT (if necessary to confirm suspect lesions on FAPI-PET/CT) and/or diagnostic laparoscopy.
- +11 more secondary outcomes
Study Arms (1)
[18F]-FAPI-74 PET/CT
EXPERIMENTAL3.0 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.
Interventions
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.
\[18F\]-FAPI-74 will be administered intravenously 60 minutes before PET/CT-scanning to be able to detect (metastases of) gastric cancer
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Related Publications (1)
Triemstra L, Spruijt SWJM, Vriens D, Vegt E, Mesker WE, Hawinkels LJAC, Saing S, Slingerland M, Kemp V, Crobach SALP, Goeman JJ, Pool M, Dibbets-Schneider P, Bennink RJ, van Berge Henegouwen MI, van Det MJ, van Etten BJ, Hartgrink HH, van Hillegersberg R, Lam MGEH, Smulders NM, Luyer MDP, Noordzij W, Owers EC, Oyen WJG, van Sandick JW, Schreurs W, de Steur WO, Stoot JHMB, Weijs LE, Wijnhoven BPL, Witteman BPL, Ruurda JP, de Geus-Oei LF; PLASTIC-3 Study Group. [18F]F-FAPI PET/CT and LAparoscopy in STagIng advanced gastric Cancer: a multicenter prospective study (PLASTIC-3 study). BMC Cancer. 2025 Nov 27;26(1):135. doi: 10.1186/s12885-025-15347-7.
PMID: 41299326DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr.
Study Record Dates
First Submitted
April 4, 2025
First Posted
June 12, 2025
Study Start
July 3, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2029
Last Updated
August 27, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 3 months and ending 5 years following article publication.
- Access Criteria
- Investigators with an approved proposal by a review committee may be granted access to research data upon reasonable request, provided necessary privacy provisions are in place. Only data from participants who have given informed consent for its use in other research is included.
Individual participant data that underlie the results reported in this article, after deidentification, and only of participants who have given informed consent to share their data for other research purposes will be shared.