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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-03

Study Completion Date

2029-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types

NCT06782412

Oesophageal Cancer Gastric Cancer Pancreatic Ductal Adenocarcinoma +3 more

RECRUITING PHASE2/PHASE3

Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.

NCT07217704

Esophageal Cancer Gastric Cancer (GC) Gastroesophageal Junction

RECRUITING PHASE3

[18F]F-FAPI PET-CT to Identify Carcinoma of Unknown Primary Origin

NCT06644716

Cancer of Unknown Primary

RECRUITING NA

FAPI-PET for Tumor Detection

NCT04571086

Malignant Neoplasm

RECRUITING

[68Ga]Ga-FAPI-46 Positron Emission Tomography (PET) Scan to Improve the Imaging of Pancreatic and Bile Duct Cancer

NCT05957250

Pancreatic Cancer Cholangiocarcinoma

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Locally Advanced Gastric Adenocarcinoma STOMACH NEOPLASM Gastric Cancer PET-CT

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

[18F]-FAPI-74 PET/CT

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.

Group Type EXPERIMENTAL

[18F]FAPI-74 PET/CT

Intervention Type DIAGNOSTIC_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-74

Intervention Type DRUG

\[18F\]-FAPI-74 will be administered intravenously 60 minutes before PET/CT-scanning to be able to detect (metastases of) gastric cancer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

[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.

Intervention Type DIAGNOSTIC_TEST

[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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No