18F Labeled FAP Targeted Molecular Probe in Early Tumor Diagnosis

NCT ID: NCT06937112

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2026-03-31

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.

Conditions

Lung Cancers; Pancreatic Cancer; Neuroendocrine Tumors; Thyroid Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

PET-CT examination

Intravenous injection of 18F-FAPI-YQ104 for PET-CT examination

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feng Wang

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Wang

Role: CONTACT

fengwangcn@hotmail.com

+8602552271491

Facility Contacts

Feng Wang, M.D.

Role: primary

fengwangcn@hotmail.com

+8602552271491

Other Identifiers

KY20250407-KS-1

Identifier Type: -

Identifier Source: org_study_id