68 Ga-FAPI-04 positron emission tomography/CT and laparoscopy for the diagnosis of occult peritoneal metastasis in newly diagnosed locally advanced gastric cancer - study protocol of a single-centre prospective cohort study

Sep 21, 2026

Accurate baseline staging is essential for treatment decisions in gastric cancer. Peritoneal metastasis is the most common metastatic pattern and is often assessed with diagnostic laparoscopy and peritoneal lavage, but laparoscopy is invasive and less cost-effective. The study protocol evaluates whether 68Ga-FAPI-04 PET/CT changes treatment strategy and determines diagnostic accuracy for detecting occult peritoneal metastasis, using laparoscopic exploration as the reference standard in a prospective cohort setting.

LanguageEnglish

CategoryHealthcare

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Pages7

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

Strengths and limitations of this study

Open access Protocol To cite: Zhang S, Hu Q, Chen X, et al. 68Ga-FAPI-04 positron emission tomography/ CT and laparoscopy for the diagnosis of occult peritoneal metastasis in newly diagnosed locally advanced gastric cancer: study protocol of a single-centre prospective cohort study. BMJ Open 2024;14:e075680 . doi:10 . 1136/ bmjopen-2023-075680 ► Prepublication history for this paper is available online. To view these files, please visit the journal online ([https://doi](https://doi). org/10 . 1136/bmjopen-2023- 075680 ) . SZ and QH contributed equally. Received 15 May 2023 Accepted 22 March 2024 © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. For numbered affiliations see end of article. Correspondence to Dr Hongfeng Gou; gouhongfeng1977@wchscu. cn and Dr Minggang Su; [suminggang@sina.com](suminggang@sina.com) 68 Ga-FAPI-04 positron emission tomography/CT and laparoscopy for the diagnosis of occult peritoneal metastasis in newly diagnosed locally advanced gastric cancer: study protocol of a singlecentre prospective cohort study Shunyu Zhang,1,2 Qiancheng Hu,1,2 Xinchuan Chen,3 Nan Zhou,1,2 Qiyue Huang,1,2 Sirui Tan,1,2 Minggang Su,4 Hongfeng Gou 1,2 ABSTRACT Introduction Accurate baseline clinical staging is critical to inform treatment decision-making for patients with gastric cancers. Peritoneal metastasis (PM) is the most common form of metastasis in gastric cancer and mainly diagnosed by diagnostic laparoscopy and peritoneal lavage evaluation. However, diagnostic laparoscopy is invasive and less cost-effective. It is urgent to develop a safe, fast and non-invasive functional imaging method to verify the peritoneal metastasis of gastric cancer. The aim of our study was to evaluate the proportion of patients in whom 68Ga-FAPI-04 positron emission tomography/CT (PET/ CT) led to a change in treatment strategy and to assess the diagnostic accuracy of 68Ga-FAPI-04 PET/CT for the detection of occult peritoneal metastasis compared with laparoscopic exploration. Methods and analysis In this single-centre, prospective diagnostic test accuracy study, a total of 48 patients with locally advanced gastric or gastro-oesophageal junction adenocarcinoma (cT4a-b, N0-3, M0, based on CT images) who are considering radical tumour surgery will be recruited. All participants will undergo 68Ga-FAPI-04 PET/ CT before the initiation of laparoscopic exploration. The primary outcome is the proportion of patients with occult peritoneal metastatic lesions detected by 68Ga-FAPI-04 PET/CT, leading to a change in therapy strategy. The secondary outcomes include the diagnostic performance of 68Ga-FAPI-04 PET/CT for occult peritoneal metastasis, including sensitivity, specificity, accuracy, positive predictive value and negative predictive value. Ethics and dissemination The study protocol was approved by the Ethics Committee of West China Hospital, Sichuan University (2022-1484) . Study results will be presented at public and scientific conferences and in peerreviewed journals. Trial registration number ChiCTR2300067591 . INTRODUCTION Gastric cancer is one of the most serious malignant tumours worldwide, ranking fifth STRENGTHS AND LIMITATIONS OF THIS STUDY ⇒ This is a prospective single-centre, single-arm study designed to test the diagnostic value of 68GaFAPI-04 positron emission tomography/CT (PET/ CT) in the occult peritoneal metastasis from gastric cancer. ⇒ Laparoscopic exploration along with peritoneal lavage cytology is employed as controls in all 68GaFAPI-04 PET/CT assays performed for the diagnosis of peritoneal metastasis in patients with gastric cancer. ⇒ Laparoscopic exploration with ‘Huaxi four-step’ has been widely performed for the diagnosis of peritoneal metastasis in our centre, preventing a missed diagnosis by practising clinicians. ⇒ The diagnosis of peritoneal metastasis between nuclear medic

FAQs

What is the study’s primary purpose?

To evaluate the proportion of patients in whom 68Ga-FAPI-04 PET/CT leads to a change in treatment strategy, and to assess diagnostic accuracy for detecting occult peritoneal metastasis versus laparoscopic exploration.

How is the reference comparison performed?

Laparoscopic exploration is used along with peritoneal lavage cytology as controls/reference for the diagnosis of peritoneal metastasis during the PET/CT assessment in the study.

Who will be recruited and how many participants are planned?

A total of 48 patients with locally advanced gastric or gastro-oesophageal junction adenocarcinoma who are considering radical surgery will be recruited for the single-centre, prospective diagnostic test accuracy study.

Sep 21, 2026

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