Actively Recruiting
Clinical Application of a Novel 18F Labeled Fibroblast Activation Protein (FAP) Targeted Molecular Probe in Early Tumor Diagnosis
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-04-22
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new molecular probe called 18F-FAPI-YQ104, which targets fibroblast activation protein (FAP), for early tumor diagnosis. This observational study focuses on patients with lung cancer, pancreatic cancer, neuroendocrine tumors, and thyroid cancer. The goal is to verify how well this probe works in detecting tumors during clinical use. Participants will receive an intravenous injection of the 18F-FAPI-YQ104 probe followed by a PET-CT examination to capture detailed images of tumor lesions. The study will observe the probe's uptake in tumor sites, measured by SUVmax values 60 minutes after administration. No additional treatment is given; instead, the study monitors the imaging results to assess the probe's diagnostic potential. During the study, participants will undergo PET-CT scans and other imaging tests such as CT or MRI. Researchers will evaluate the images to measure tumor activity and probe uptake. Safety assessments include checking kidney and liver function, blood counts, and monitoring for allergic reactions. The study will last from April 2025 to March 2026 and includes adults aged 18 to 75 years who have confirmed tumors and meet health criteria.
CONDITIONS
Brief Title
18F Labeled FAP Targeted Molecular Probe in Early Tumor Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer for the trial with signed informed consent by the patient or legal guardian
- Age between 18 and 75 years, any gender
- Tumor lesions identified by imaging methods such as CT or MRI
- Diagnosis of lung cancer, thyroid cancer, pancreatic cancer, melanoma, or neuroendocrine tumors with final pathological confirmation
- Kidney function: GFR greater than 50 ml/min, ERPF greater than 280 ml/min
- Platelet count above 75,000/µL, white blood cell count above 3,000/µL
- Liver enzymes ALT and AST less than three times the normal value
You will not qualify if you...
- History of allergies to drugs similar to FAPI or current allergic diseases
- Participation in other clinical drug research or recent clinical drug studies (excluding vitamins and minerals)
- Uncontrolled serious infections or chronic diseases including HIV, hepatitis B or C, serious mental, neurological, cardiovascular, or respiratory diseases
- Low red blood cell count (RBC below 4 x 10¹²), low white blood cell count (WBC below 3 x 10⁹), low hemoglobin (below 110 g/L), or low platelet count (below 75,000 x 10⁹)
- Significant liver or kidney dysfunction with GFR less than 50 ml/min
- Tumor burden over 50% or severe spinal cord compression
- Expected survival less than six months or chemotherapy within six months
- Severe acute comorbidities or refractory mental disorders
- Pregnant or breastfeeding women
- Physical condition unsuitable for radiation examination
- Any other condition deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo PET-CT examination involving an intravenous injection of 18F-FAPI-YQ104 to assess tumor lesions.
1 visit (in-person)
Duration - Up to 6 months
Participants are observed following the diagnostic evaluation to monitor outcomes and safety.
Follow-up visits as needed
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210001
Actively Recruiting
Research Team
F
Feng Wang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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