NCT06543108

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
32mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Jan 2024Dec 2028

Study Start

First participant enrolled

January 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

August 7, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

August 3, 2024

Last Update Submit

August 3, 2024

Conditions

Outcome Measures

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

    2 years

Secondary Outcomes (1)

  • Detection rate of peritoneal metastasis in gastric cancer

    2 years

Interventions

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Gastric cancer

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2024

First Posted

August 7, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

August 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations