Locally Advanced Gastric AdenocarcinomaPhase 2/3PLASTIC-3NCT07018661
[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer
A Phase 2/3 study testing [18F]FAPI-74 PET/CT and [18F]-FAPI-74 in people with Locally Advanced Gastric Adenocarcinoma and STOMACH NEOPLASM, run by Leiden University Medical Center at 10 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Gastric Adenocarcinoma, STOMACH NEOPLASM, Gastric Cancer
- What is being tested?
- [18F]FAPI-74 PET/CT and [18F]-FAPI-74
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 10 sitesNetherlands
- Study dates
- 3 Jul 2025to Jan 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Netherlands10 sites, 10 recruiting
- Not yet recruiting
ZGT
Almelo
Marc van Det, M.D., PhD, +31 71 526 6029, s.w.j.m.spruijt@lumc.nl
Leo Weijs, M.D., PhD
- Not yet recruiting
Amsterdam UMC
Amsterdam
Mark van Berge Henegouwen, Professor, M.D., +31 71 526 6029, s.w.j.m.spruijt@lumc.nl
Ben Zwezerijnen, M.D.
- Not yet recruiting
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam
Johanna van Sandick, M.D., PhD, +31 71 526 6029, s.w.j.m.spruijt@lumc.nl
Emilia Owers, M.D., PhD
- Not yet recruiting
Rijnstate
Arnhem
Wim Oyen, Professor, M.D., +31 71 526 6029, s.w.j.m.spruijt@lumc.nl
Bart Witteman, M.D., PhD
- Not yet recruiting
Catharina Ziekenhuis
Eindhoven
Misha Luyer, M.D., PhD, +31 71 526 6029, s.w.j.m.spruijt@lumc.nl
Nanda Louwers, M.D., PhD
- Not yet recruiting
Zuyderland
Geleen
Jan Stoot, M.D., PhD, +31 71 526 6029, s.w.j.m.spruijt@lumc.nl
Wendy Schreurs, M.D.
- Not yet recruiting
UMC Groningen
Groningen
Walter Noordzij, M.D., PhD, +31 71 526 6029, s.w.j.m.spruijt@lumc.nl
Boudewijn van Etten, M.D., PhD
- Recruiting
Leids Universitair Medisch Centrum
Leiden
Sarah Spruijt, M.D., +31 71 526 6029, s.w.j.m.spruijt@lumc.nl
Lioe-Fee de Geus-Oei, Professor, M.D.
- Not yet recruiting
Erasmus MC
Rotterdam
Erik Vegt, M.D., PhD, +31 71 526 6029, s.w.j.m.spruijt@lumc.nl
Bas Wijnhoven, Professor, M.D.
- Not yet recruiting
UMC Utrecht
Utrecht
Jelle Ruurda, Professor, M.D., +31 71 526 6029, s.w.j.m.spruijt@lumc.nl
Marnix Lam, Professor, M.D.
About this study
Official title: [18F]F-FAPI PET/CT and LAparoscopy in STagIng Advanced Gastric Cancer - a Multicenter Prospective Study
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:
Read more
- 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
- Being tested
- [18F]FAPI-74 PET/CT, [18F]-FAPI-74
- Keywords
- FAPI, 18F-FAPI-74, PET/CT, Imaging biomarker, Gastrectomy, Gastric Cancer, Diagnostics
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FAPI-74 PET/CTDiagnostic test
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-74Drug
[18F]-FAPI-74 will be administered intravenously 60 minutes before PET/CT-scanning to be able to detect (metastases of) gastric cancer
| Study group | Role | What they receive |
|---|---|---|
| [18F]-FAPI-74 PET/CT | Experimental | 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. Receives: Diagnostic Test: [18F]FAPI-74 PET/CT; Drug: [18F]-FAPI-74 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Diagnostic performance measured in sensitivity, specificity, diagnostic accuracy, positive predictive value and negative predictive value using histopathologic tumor tissue collected during biopsy, staging laparoscopy and follow-up imaging as reference test
Measured: 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
Proportion of patients with relevant incidental findings (e.g. second primary tumors)
Measured: 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
Patients' extra burden of undergoing additional diagnostics due to incidental and/or non-specific [18F]AlF-FAPI-74 PET/CT findings using EORTC-QLQ-C30. This includes five functional scales, three symptom scales, a global health status/QoL scale and six single items. All of the scales and single-item measures range in score from 0 to 100.
A high score for a functional scale represents a high/healthy level of functioning.
A high score for the global health status / QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: 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
Patients' extra burden of undergoing additional diagnostics due to incidental and/or non-specific [18F]AlF-FAPI-74 PET/CT findings using EQ-5D-5L. This comprises 5 dimensions and each dimension has five response levels, from no problems to unable to/extreme problems. Health states can be summarised using a 5 digit code (one digit for each dimension, no problems is coded as one and extreme problems as 5 and everything in between, e.g. 21111) or represented by a single summary number (index value), through which QALY's can be calculated. The index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension.
Measured: 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
Patients' extra burden of undergoing additional diagnostics due to incidental and/or non-specific [18F]AlF-FAPI-74 PET/CT findings using a Patient Reported Experience Measure (PREM) questionnaire. This includes questions designed to capture the differences in patient burden between imaging with FAPI-PET/CT and staging laparoscopy. The scale ranges from 1 (strongly agree/not annoying at all) to 5 (strongly disagree/very annoying). A higher score represents a worse outcome.
Measured: 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.
Diagnostic time delay due to extra investigation
Time between pre-diagnostic and post-diagnostic MDT meetings
Measured: Immediately after completion of clinical staging (after post-diagnostic MDT). 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.
Safety data regarding clinical use of [18F]FAPI-74 PET/CT
The occurrence, type, and severity of (serious) adverse events
Measured: From start of injection of [18F]FAPI-74 up to 24 hours after administration.
FAPI-PET based PCI scores
Correlation between [18F]AlF-FAPI-74 PET-based Peritoneal Cancer Index (PCI) scores and staging laparoscopy based PCI scores as a reference standard for 'true' intraperitoneal tumor load (this is done only for the LUMC patients).
Measured: Immediately after staging laparoscopy, which takes place after FAPI-PET/CT.
FAPI uptake and histopathological tumor scores
Correlation between PCI-regional FAPI uptake and PCI-regional histopathological tumor scores (this is done only for LUMC patients).
Measured: Immediately after staging laparoscopy
FAP-expression
Expression of CAF content as measured by tumor-stroma ratio (TSR) on tissue samples from D1D2/CRITICS and relation with FAP expression. TSR according to van Pelt and Mesker et al.
Measured: Baseline, before study procedure (for D1D2/CRITICS samples) and immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed, for PLASTIC-3 patients)
TSR, FAP expression and FAPI-PET/CT signals
Analysis of TSR and FAP expression and correlation to [18F]AlF-FAPI-74 PET/CT signal
Measured: Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed)
FAP expressing CAF subsets
Analysis of all FAP expressing CAF subsets in obtained patient samples using imaging mass cytometry
Measured: Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed)
Patient burden
Patient burden using a developed patient reported experience measure (PREM) questionnaire
Measured: Immediately after completion of clinical staging (after post-diagnostic MDT). 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.
Health-related quality of life
Quality of life as measured using the EORTC-QLQ-C30 questionnaire and compared to PLASTIC. The EORTC-QLQ-C30 includes five functional scales, three symptom scales, a global health status/QoL scale and six single items. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status / QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months
Health-related quality of life
Quality of life as measured using the EQ-5D5L questionnaire and compared to PLASTIC. This comprises 5 dimensions and each dimension has five response levels, from no problems to unable to/extreme problems. Health states can be summarised using a 5 digit code (one digit for each dimension, no problems is coded as one and extreme problems as 5 and everything in between, e.g. 21111) or represented by a single summary number (index value), through which QALY's can be calculated. The index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension.
Measured: At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months
Costs of [18F]FAPI-74 PET/CT
Costs of [18F]AlF- FAPI-74 PET/CT compared with staging laparoscopy compared to PLASTIC for patients who received SL only, using the SL bottom-costing approach numbers from the PLASTIC-cost analysis study and resource use questionnaires
Measured: At 3 and 12 months after completion of clinical staging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start3 Jul 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lioe-Fee de Geus-Oei, MD PhD, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018661
- Sponsor's protocol ID
- 134826
- Other IDs
- 2024-513255-32-00
- Acronym
- PLASTIC-3
- Status last verified
- Aug 2025
- First submitted
- 4 Apr 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41299326
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]F-FAPI PET/CT and LAparoscopy in STagIng Advanced Gastric Cancer - a Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT07018661
- Acronym / sponsor ID
- PLASTIC-3 / 134826
- Keywords
- FAPI, 18F-FAPI-74, PET/CT, Imaging biomarker, Gastrectomy, Gastric Cancer, Diagnostics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]-FAPI-74 PET/CT | Experimental | Diagnostic Test: [18F]FAPI-74 PET/CT, Drug: [18F]-FAPI-743.0 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FAPI-74 PET/CTPatients 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. | Diagnostic test | [18F]-FAPI-74 PET/CT |
| [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 | Drug | [18F]-FAPI-74 PET/CT |
Primary outcome
Change in treatment intent
Time frame: For each patient from enrollment through study completion, an average of 1 year.
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
Change in diagnostic work-up
Time frame: 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
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
16 secondary outcomes
Diagnostic performance
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Diagnostic time delay due to extra investigation
Time frame: Immediately after completion of clinical staging (after post-diagnostic MDT). 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.
Safety data regarding clinical use of [18F]FAPI-74 PET/CT
Time frame: From start of injection of [18F]FAPI-74 up to 24 hours after administration.
FAPI-PET based PCI scores
Time frame: Immediately after staging laparoscopy, which takes place after FAPI-PET/CT.
FAPI uptake and histopathological tumor scores
Time frame: Immediately after staging laparoscopy
FAP-expression
Time frame: Baseline, before study procedure (for D1D2/CRITICS samples) and immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed, for PLASTIC-3 patients)
TSR, FAP expression and FAPI-PET/CT signals
Time frame: Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed)
FAP expressing CAF subsets
Time frame: Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed)
Patient burden
Time frame: Immediately after completion of clinical staging (after post-diagnostic MDT). 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.
Health-related quality of life
Time frame: At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months
Health-related quality of life
Time frame: At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months
Costs of [18F]FAPI-74 PET/CT
Time frame: At 3 and 12 months after completion of clinical staging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Derived from this study: PubMed 41299326Triemstra 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing [18F]FAPI-74 PET/CT and [18F]-FAPI-74 in people with Locally Advanced Gastric Adenocarcinoma and STOMACH NEOPLASM, run by Leiden University Medical Center at 10 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Spruijt, M.D. (+31 71 526 6029, s.w.j.m.spruijt@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in treatment intent (time frame: For each patient from enrollment through study completion, an average of 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07018661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.