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Clinical Study on the Diagnosis, Staging, and Recurrence Monitoring of Gastrointestinal Tumors by PET/CT and Enhanced CT Imaging of Fluoride [18F] Fibrostatin Injection (18FAl NOTA-FAPI)

Clinical Study on the Diagnosis, Staging, and Recurrence Monitoring of Gastrointestinal Tumors by PET/CT and Enhanced CT Imaging of Fluoride [18F] Fibrostatin Injection (18FAl NOTA-FAPI)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077519
Enrollment
Unknown
Registered
2023-11-10
Start date
2023-11-20
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Gastrointestinal cancer

Interventions

Index test:Fluoride [18F] Fibrostatin Injection 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: Those who meet all of the following conditions are eligible for selection: (1) Age = 18 years old; (2) Pathologically confirmed gastrointestinal tumor and planned surgical resection/exploration patients (including primary or recurrent metastatic tumors in the gastrointestinal tract); (3) Received enhanced CT examination of the lesion site within two weeks; (4) According to the doctor's judgment, the expected survival period is>3 months; (5) Voluntarily sign an informed consent form; Willing and able to follow the research protocol.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria are not eligible for enrollment: (1) Individuals with a known history of allergies to fluoride [18F] and/or endostatin injection or its excipients; (2) Those who cannot tolerate intravenous administration methods (such as a history of needle or blood sickness); Researchers believe that imaging examinations such as PET are not suitable or cannot be completed due to special reasons, including claustrophobia, radiation phobia, etc; (3) Patients who have received anti-tumor therapy before examination, or who have received neoadjuvant chemotherapy/targeted therapy for tumor reduction from examination to surgery; (4) Pregnant and lactating women; (5) Practitioners who require long-term exposure to radioactive conditions; (6) Serious diseases such as heart, kidney, lungs, blood vessels, nerves, and mental systems, immune deficiency diseases, and hepatitis/cirrhosis; (7) Participated in other interventional clinical trials within one month prior to screening; (8) Patients undergoing chemotherapy, immunotherapy, or molecular targeted therapy; (9) There are other situations where the researcher believes it is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
SUVmax;Percentage of positive patients;Percentage of positive lesions in total evaluated lesions;sensitiveness;specificity;accuracy;

Countries

China

Contacts

Public ContactJing Wang

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

fmmukf@qq.com+86 29 8477 1048

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026