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A prospective, open label, single arm, multicenter study evaluating the diagnostic staging value of 68Ga-FAPI-04 PET/CT for gastric cancer

A prospective, open label, single arm, multicenter study evaluating the diagnostic staging value of 68Ga-FAPI-04 PET/CT for gastric cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400081233
Enrollment
Unknown
Registered
2024-02-27
Start date
2024-02-29
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Index test:68Ga-FAPI-04 PET/CT

Sponsors

the First Affiliated Hospital of the People's Liberation Army Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign an informed consent form. 2. Age = 18 years old. 3. Gastric cancer patients who are highly suspected or diagnosed through gastroscopy or routine imaging examination, with pathological types including adenocarcinoma, signet ring cell carcinoma, and low adhesion carcinoma. According to the doctor's assessment, the estimated survival period is 3 months. 5. Agree to implement strict contraception for at least 28 days after administration of 68Ga-FAPI-04. Willing and able to follow the research protocol.

Exclusion criteria

Exclusion criteria: Patients diagnosed with other malignant tumors in the past year. 2. Patients diagnosed with other pathological types of gastric cancer or other gastric malignancies during follow-up. 3. Patients who are known to be allergic to contrast-enhanced CT contrast agents and cannot undergo contrast-enhanced CT examination due to renal dysfunction or other reasons. 4. Patients undergoing any anti-tumor treatment between enhanced CT and 68Ga-FAPI-04 PET/CT examination. 5. Pregnant or lactating women. 6. Unable to cooperate with lying on the PET/CT scanning bed during the scanning period or intolerant to PET examination. 7. Patients who have received or are currently receiving radiotherapy, chemotherapy, immunotherapy, or molecular targeted therapy. 8. Have participated in other intervention clinical trials within the previous month of screening. 9. Patients who have been lost to follow-up. 10. According to the evaluation of the researchers, the subjects may have other circumstances that may affect the study or are not suitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
SUVmax;TBR;SUVmean;

Secondary

MeasureTime frame
TP;FP;FN;TN;

Countries

China

Contacts

Public ContactJing Wang

the First Affiliated Hospital of the People's Liberation Army Air Force Military Medical University

2326604944@qq.com+86 29 8477 1048

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 13, 2026