Nanjing First Hospital, Nanjing Medical University
Phase
Observational
Started
2025-04-10
Last updated
2025-04-22
Condition(s) studied
Lung CancersPancreatic CancerNeuroendocrine TumorsThyroid Cancer
Investigational drug(s) / intervention(s)
PET-CT examination
PET-CT examination: Intravenous injection of 18F-FAPI-YQ104 for PET-CT examination
Study summary
Evaluate the safety of the novel FAP targeted molecular probe 18F-FAPI-YQ104 labeled with radioactive isotopes in clinical applications and verify its effectiveness in tumor diagnosis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
\- 1. Volunteer for the trial, with the patient or their legal guardian signing the informed consent form; 2. Volunteers are not limited by gender, and the age range is from 18 to 75 years old, including both ends; 3. Other imaging examination methods (CT, MRI, etc.) revealed tumor occupying lesions; 4. Patients with lung cancer, thyroid cancer, pancreatic cancer, melanoma, and neuroendocrine tumors who can obtain the final pathological results.
5\. Kidney: GFR \> 50 ml/min, ERPF \> 280 ml/min, platelet count (PLT) \> 75,000/μL, white blood cell (WBC) \> 3,000/μL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the normal value.
Exclusion Criteria:
* 1\. Individuals with a history of allergies to similar drugs (drugs with similar chemical or biological components to FAPI), allergic constitution, or current allergic diseases; 2. Those who are currently conducting clinical research on other drugs or have participated in any clinical research on drugs (excluding vitamins and minerals); 3. There are other clinical problems that are difficult to control (such as HIV, hepatitis C virus infection or active hepatitis B, or other serious chronic infections and serious mental, neurological, cardiovascular, respiratory and other system diseases); 4. Red blood cell RBC\<4 × 1012, white blood cell WBC\<3 × 109, hemoglobin\<110g/L, PLT\<75000×109; 5. Significant abnormalities in liver and kidney function, with GFR less than 50 ml/min; 6. Tumor burden greater than 50%, or significant spinal cord compression; 7. Expected survival period is less than six months; Chemotherapy within June; 8. Having severe acute comorbidities or severe refractory mental disorders; 9. Pregnant and lactating women (where pregnancy is defined as a positive urine pregnancy study); 10. Patients whose physical condition is not suitable for radiation examination; 11. Other situations that researchers consider unsuitable for participating in the experiment.
Primary outcome measure(s)
SUVmax of lesion uptake value — 60 minutes after administration
Trial sites (1)
Facility
City
Region
Status
Nanjing First Hospital
Nanjing
Jiangsu
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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