[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

Overview

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

Interventions

• Diagnostic test [18F]FAPI-74 PET/CT
  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.
• Drug [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

Primary outcome measures

• Change in treatment intent [Time frame: For each patient from enrollment through study completion, an average of 1 year.]
• 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]

Secondary outcome measures (12)

• 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)]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Netherlands · 10 centers

• ZGT — Almelo
• Amsterdam UMC — Amsterdam
• Netherlands Cancer Institute - Antoni van Leeuwenhoek — Amsterdam
• Rijnstate — Arnhem
• Catharina Ziekenhuis — Eindhoven
• Zuyderland — Geleen
• UMC Groningen — Groningen
• Leids Universitair Medisch Centrum — Leiden
• … and 2 more centers

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, PMID 41299326

Identifiers

NCT: NCT07018661 · 134826 · 2024-513255-32-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗