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Not yet recruitingNCT07510867Updated Apr 6, 2026

18F-FAPI PET/CT and MRI in Gastric Cancer

An observational study in Gastric Cancer, sponsored by First Affiliated Hospital of Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by First Affiliated Hospital of Zhejiang University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
230
Ages
20 Years to 80 Years
Sex
All
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Study summary

The purpose of this study was to evaluate the diagnostic efficacy and prognostic value of 18F-FAPI PET/CT combined with multiparameter MRI in gastric cancer.

Read the detailed description

Evaluation of the diagnostic and staging efficacy of 18F-FAPI PET/CT combined with multiparametric MRI This study aims to evaluate the sensitivity, specificity, and accuracy of 18F-FAPI PET/CT combined with multiparametric MRI in gastric cancer patients, providing a basis for clinical application. By performing 18F-FAPI PET/CT and multiparametric MRI imaging on gastric cancer patients, relevant data were collected and analyzed to assess their performance in early diagnosis, staging, and recurrence monitoring. The goal is to provide a scientific basis for clinical physicians in the diagnosis, precise staging, and treatment decision-making of gastric cancer.

2.1.2 Comparative Study of 18F-FAPI PET/CT and Contrast-Enhanced MRI A comparative study of 18F-FAPI PET/CT and contrast-enhanced MRI in gastric cancer patients to evaluate the differences in tumor detection sensitivity, specificity, and accuracy among various imaging modalities. The study aims to clarify their advantages in clinical applications for gastric cancer. The research will focus on analyzing the differences in tumor size, location, metastasis, and pathological characteristics detected by each imaging technique, and explore the potential of 18F-FAPI PET/CT combined with multiparametric MRI in improving the diagnostic accuracy and early detection of gastric cancer.

2.1.3 Analysis of diagnostic differences in gastric cancer subgroups using 18F-FAP PET/CT combined with multiparametric MRI Subgroup analysis was performed based on pathological type, stage, and molecular subtype, stratified by disease pathological type, stage (early/progressive/advanced), and molecular subtype, to evaluate the differences in sensitivity and specificity of 18F-FAPI PET/CT combined with multiparameter MRI across different patient populations. This study will help identify which specific types of gastric cancer patients are more likely to benefit from 18F-FAPI PET/CT, thereby providing a basis for the development of individualized treatment plans.

2.1.4 Evaluation of Multimodal Imaging Combinations in Predicting Gastric Cancer Prognosis Based on TNM staging and PERCIST criteria, this study evaluates the post-treatment reassessment, efficacy prediction, and prognostic assessment (AUC comparison of PFS/OS) of 18F-FAPI PET/CT combined with multiparametric MRI in gastric cancer. The research aims to analyze the multimodal imaging combination's monitoring capability for tumor response post-treatment and its value in prognostic evaluation, providing clinicians with a more precise tool for therapeutic outcome assessment. It tracks the time from diagnosis to specific events (e.g., CR, PR, SD, PD, recurrence, death) in gastric cancer patients to identify influencing factors. Survival rates over time are plotted using Kaplan-Meier curves to visually compare survival differences across groups. Additionally, Cox proportional hazards model-based multivariate regression quantifies the contribution of factors such as age and pathological stage to survival risk, aiding clinical decision-making.

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Conditions studied

  • Gastric Cancer

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Keywords

  • FAPI
  • PET
  • MRI
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In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 230 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The purpose of this study was to evaluate the diagnostic efficacy and prognostic value of 18F-FAPI PET/CT combined with multiparameter MRI in gastric cancer.

Primary endpoint: Diagnostic efficacy of 18F-FAPI PET/CT combined with multiparametric MRI in gastric cancer patients (sensitivity, specificity, accuracy) secondary end points:

  • To compare the diagnostic performance differences between 18F-FAPI PET/CT and contrast-enhanced MRI in the clinical application of gastric cancer; ② Analysis of diagnostic differences in the subgroup (pathological, genetic, etc.) of patients using 18F-FAPI PET/CT combined with multiparameter MRI; ③ Evaluation of 18F-FAPI PET/CT combined with multiparameter MRI in predicting the prognosis of gastric cancer.

Inclusion criteria

  1. Patients suspected or diagnosed with gastric cancer
  2. 18F-FAPI PET/CT has been performed
  3. Gastric MRI with both non-contrast and contrast-enhanced scans performed

Exclusion criteria

Exclusion Criteria:

  1. Concurrent presence of other active malignant tumors or a history of other malignant tumors within the past 5 years;
  2. Severe uncontrollable diseases or active infections;
  3. Ineligible participants who cannot provide informed consent for the study;
  4. Patients with suboptimal image quality in 18F-FAPI PET/CT
  5. Patients with suboptimal MRI image quality enhancement
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
230 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testpatients with suspected or confirmed gastric cancer who have undergone 18F-FAPI PET/CT and MRI (non-contrast + contrast-enhanced scans)

    A comparative study of 18F-FAPI PET/CT and contrast-enhanced MRI in gastric cancer patients to evaluate the differences in tumor detection sensitivity, specificity, and accuracy among various imaging modalities. The study aims to clarify their advantages in clinical applications for gastric cancer. The research will focus on analyzing the differences in tumor size, location, metastasis, and pathological characteristics detected by each imaging technique, and explore the potential of 18F-FAPI PET/CT combined with multiparametric MRI in improving the diagnostic accuracy and early detection of gastric cancer.

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What researchers measure

Primary outcomes

  1. Diagnostic efficacy

    Sensitivity, specificity, positive and negative predictive value of 18F-OC PET/CT and PET/MR Imaging in neuroendocrine neoplasms

    Time frame: through study completion, an average of 1.5 year

Secondary outcomes

  1. Standard uptake value (SUV)of tumor

    This measure evaluates the association between baseline 18F-FAPI PET parameters (e.g., SUVmax, SUVmean).

    Time frame: through study completion, 3-4 years

  2. Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients

    PFS will be defined as the time from diagnosis to disease progression or relapse, assessed using the Kaplan-Meier method and Cox proportional hazards model.(PFS in months)

    Time frame: through study completion, 3-4 years

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Study locations

1 site
  • Pet /Ct/Mri
    Hangzhou, Zhejiang 310003, China
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References and documents

Study documents

  • Protocol and informed consent form · Nov 24, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07510867
Lead sponsor
First Affiliated Hospital of Zhejiang University
Responsible party
Sponsor
First posted
Apr 6, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Jan 31, 2028 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Apr 6, 2026

Study contacts

Donghe Chen
Contact
chendonghe@zju.edu.cn
0571-87236432

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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