Clinical trial NCT07018661: [18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer
Official title: [18F]F-FAPI PET/CT and LAparoscopy in STagIng Advanced Gastric Cancer - a Multicenter Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Locally Advanced Gastric Adenocarcinoma
STOMACH NEOPLASM
Gastric Cancer
PET-CT
Keywords: FAPI
18F-FAPI-74
PET/CT
Imaging biomarker
Gastrectomy
Gastric Cancer
Diagnostics
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


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).

Primary outcomes:
measure: Change in treatment intent
timeFrame: For each patient from enrollment through study completion, an average of 1 year.
measure: Change in diagnostic work-up
timeFrame: 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:
measure: Diagnostic performance
timeFrame: 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
measure: Incidental findings
timeFrame: 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
measure: Impact of incidental and/or non-specific findings
timeFrame: At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months]
measure: Impact of incidental and/or non-specific findings
timeFrame: At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months]
measure: Impact of incidental and/or non-specific findings
timeFrame: 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.
measure: Diagnostic time delay due to extra investigation
timeFrame: 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.
measure: Safety data regarding clinical use of [18F]FAPI-74 PET/CT
timeFrame: From start of injection of [18F]FAPI-74 up to 24 hours after administration.
measure: FAPI-PET based PCI scores
timeFrame: Immediately after staging laparoscopy, which takes place after FAPI-PET/CT.
measure: FAPI uptake and histopathological tumor scores
timeFrame: Immediately after staging laparoscopy
measure: FAP-expression
timeFrame: 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)
measure: TSR, FAP expression and FAPI-PET/CT signals
timeFrame: Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed)
measure: FAP expressing CAF subsets
timeFrame: Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed)
measure: Patient burden
timeFrame: 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.
measure: Health-related quality of life
timeFrame: At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months
measure: Health-related quality of life
timeFrame: At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months
measure: Costs of [18F]FAPI-74 PET/CT
timeFrame: At 3 and 12 months after completion of clinical staging
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: ZGT
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Geleen
country: Netherlands
facility: Zuyderland
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References: