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RecruitingNCT06543108Updated Aug 7, 2024

Preliminary Study on the Diagnostic Value Comparison of 18F-FAPI-04 PET/CT and PET/MR in Gastric Cancer

An observational study in Gastric Cancer, sponsored by Hunan Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Hunan Cancer Hospital · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 90 Years
Sex
All
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Study summary

This project aims to comprehensively analyze the diagnostic efficacy of SUVmax, SUVean, TLG, MTV, etc. in gastric cancer through 18F-FAPI-04 PET/CT imaging combined with serum tumor markers and other methods, and construct a molecular imaging diagnostic model for gastric cancer; Next, analyze the diagnostic efficacy of 18F-FAPI-04 PET/CT and PET/MR multimodal imaging in evaluating SUVmax, PET/CT-PCI, and PET/MR-PCI for gastric cancer peritoneal metastasis, and construct a molecular imaging diagnostic model for gastric cancer peritoneal metastasis; Exploring the clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancer.

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Conditions studied

  • Gastric Cancer

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03

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 30 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Hunan Cancer Hospital is the lead sponsor of 54 studies on the registry; 28 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Gastric cancer

Inclusion criteria

  1. Age over 18 years old;
  2. Diagnosed as a patient with gastric cancer;
  3. Receive FAPI PET/CT and FDG PET/CT imaging within one week;
  4. Perform serum tumor marker testing one week before and after scanning

Exclusion criteria

Exclusion Criteria:

  1. History of other malignant tumors;
  2. Patients with severe infections, severe underlying diseases such as heart, kidney, and liver;
  3. Patients with contraindications for PET-CT examination, poor physical condition, and inability to tolerate the examination;
  4. Patients with unorganized pathology or incomplete clinical data
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Study design

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

Interventions

  • Diagnostic testThe clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancer

    The clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancer

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What researchers measure

Primary outcomes

  1. 18F-FAPI-04 PET imaging diagnosis of gastric cancer detection rate

    Exploring the feasibility of using targeted fibroblast activation protein (FAP) PET/CT imaging for gastric cancer; Compare the advantages and disadvantages of 18F-FAPI-04 and 18F-FDG in gastric cancer imaging, explore the clinical application value of 18F-FAPI-04 PET/CT in gastric cancer imaging, and construct a molecular imaging diagnostic model for gastric cancer

    Time frame: 2 years

Secondary outcomes

  1. Detection rate of peritoneal metastasis in gastric cancer

    Comparison of the diagnostic value of 18F-FAPI-04 PET/CT and PET/MR for peritoneal metastasis of gastric cancer, and construction of a molecular imaging diagnostic model for peritoneal metastasis of gastric cancer

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • Hunan Cancer hospital
    Changsha, Hunan 410000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2024, 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
NCT06543108
Lead sponsor
Hunan Cancer Hospital
Responsible party
Hui Ye (Professor, Hunan Cancer Hospital) — Principal investigator
First posted
Aug 7, 2024
Start date
Jan 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Aug 7, 2024

Study contacts

Hui Ye
Contact
yuxin75831@163.com
86-13755117105

Oversight

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

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