Status:
RECRUITING
18F Labeled FAP Targeted Molecular Probe in Early Tumor Diagnosis
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Lung Cancers
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Brief 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 Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
April 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06937112
Start Date
April 10 2025
End Date
March 31 2026
Last Update
April 22 2025
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210001