Clinical trial NCT06937112: 18F Labeled FAP Targeted Molecular Probe in Early Tumor Diagnosis
Official title: Clinical Application of a Novel 18F Labeled Fibroblast Activation Protein (FAP) Targeted Molecular Probe in Early Tumor Diagnosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancers
Pancreatic Cancer
Neuroendocrine Tumors
Thyroid Cancer
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants were recruited through hospital electronic records and community health centers

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 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 outcomes:
measure: SUVmax of lesion uptake value
timeFrame: 60 minutes after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
References: