Using a new molecular probe for early diagnosis of tumors
Clinical Application of a Novel 18F Labeled Fibroblast Activation Protein (FAP) Targeted Molecular Probe in Early Tumor Diagnosis
Nanjing First Hospital, Nanjing Medical University · NCT06937112
This study is testing a new imaging tool to see if it can help doctors find different types of tumors earlier in patients aged 18 to 75 who already have confirmed tumor lesions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University (other) |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06937112 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and effectiveness of a novel FAP targeted molecular probe, 18F-FAPI-YQ104, labeled with radioactive isotopes for diagnosing tumors. Participants will undergo PET-CT examinations to assess the probe's ability to identify lung cancers, pancreatic cancer, neuroendocrine tumors, and thyroid cancer. The study aims to gather data on the probe's performance in clinical applications, focusing on patients with confirmed tumor lesions. The trial includes a diverse patient population aged 18 to 75 years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with confirmed tumor lesions from lung cancer, pancreatic cancer, neuroendocrine tumors, or thyroid cancer.
Not a fit: Patients with a history of allergies to similar drugs or those currently involved in other clinical research may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis of various types of tumors, enhancing treatment outcomes.
How similar studies have performed: While this approach is innovative, similar studies using targeted molecular probes have shown promise in tumor diagnosis.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- Nanjing First Hospital — Nanjing, Jiangsu, China (RECRUITING)
Study contacts
- Study coordinator: Feng Wang
- Email: fengwangcn@hotmail.com
- Phone: +8602552271491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Cancers, Pancreatic Cancer, Neuroendocrine Tumors, Thyroid Cancer