[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer

Официальное название

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

Обзор

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

Вмешательства

• Диагностический тест [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.
• Препарат [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

Первичные конечные точки

• Change in treatment intent [Срок оценки: For each patient from enrollment through study completion, an average of 1 year.]
• Change in diagnostic work-up [Срок оценки: 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]

Вторичные конечные точки (12)

• Diagnostic performance [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From start of injection of [18F]FAPI-74 up to 24 hours after administration.]
• FAPI-PET based PCI scores [Срок оценки: Immediately after staging laparoscopy, which takes place after FAPI-PET/CT.]
• FAPI uptake and histopathological tumor scores [Срок оценки: Immediately after staging laparoscopy]
• FAP-expression [Срок оценки: 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 [Срок оценки: Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed)]
• FAP expressing CAF subsets [Срок оценки: Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Нидерланды · 10 центров

• 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
• … и ещё 2 центра

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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