A Multicenter, Open, Non-inferiority Phase III Clinical Study to Evaluate the Efficacy of 18F-Alfatide Injection PET/CT Compared With 18F-FDG PET/CT in the Diagnosis of Lymph Node Metastasis in Non-small Cell Lung Cancer

18F-Alfatide-003

This is a multicenter, open, non-inferiority Phase III clinical study to evaluate the efficacy of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer. This trial will include 428 patients with non-small cell lung cancer confirmed by imaging, histopathology and/or cytology or highly suspected by investigators, suspected lymph node metastasis and proposed radical surgery and lymph node dissection. Eligible subjects will receive 18F-Alfatide Injection PET/CT and 18F-FDG PET/CT scans within 1 week. Subjects will undergo relevant security checks before and after each scan. The subjects underwent radical surgery and lymph node dissection within 2 weeks of completing both scans, and the obtained lymph nodes were pathologically examined as the gold standard to compare the diagnostic efficacy of 18F-Alfatide versus 18F-FDG for lymph node metastasis.

2024-08-01

2026-08-01

2026-12-01

Not yet recruiting

Early phase I

428

Inclusion Criteria: 1. The subjects understand the clinical trial procedure and sign the informed consent in person; 2. Patients with non-small cell lung cancer confirmed or highly suspected by investigators based on prior history, imaging, histopathology, and/or cytology, suspected lymph node metastasis and proposed radical surgery and lymph node dissection; 3. Over 18 years old (including 18 years old); 4. ECOG function status score 0\~1 points ; 5. Expected survival \> 3 months. Exclusion Criteria: 1. Known allergic history to 18F-Alfatide Injection and 18F-FDG injection or its excipients; 2. Patients who cannot tolerate intravenous drug administration (such as needle fainting and blood fainting history); 3. Patients who are not suitable for PET or cannot complete PET or other imaging tests due to special reasons, including claustrophobia and radiophobia; 4. Workers who need to be exposed to radioactive conditions for a long time; 5. Patients with renal insufficiency were defined as the standard endogenous creatinine clearance (Ccr) estimated by the Cockcroft-Gault formula \<60 ml/min, Ccr(ml/min)=\[(140-age)× body weight (kg)\]/\[72×Scr(mg/dl)\], and the calculated result for females was 0.85; 6. Fasting blood glucose level more than 7.0 mmol/L; 7. There are serious infections that cannot be controlled before screening; 8. Any serious disease that cannot be controlled, such as severe heart dysfunction (such as unstable angina pectoris, myocardial infarction, heart failure, etc.), a large number of pleural effusion patients, patients with mental illness, etc.; 9. Previously diagnosed with other malignant tumors, except in the following cases: * Adequately treated basal or squamous cell carcinoma (requiring adequate wound healing prior to enrollment in the study); * Carcinoma in situ of cervical or breast cancer with curative treatment and no signs of recurrence for at least 3 years prior to the study; * The primary malignancy has been completely removed and in complete remission for ≥5 years. 10. Participants who had participated in clinical trials of radiopharmaceuticals within 1 year before screening; 11. Participating in other interventional clinical trials within 1 month before screening; 12. Poor general condition, heart, lung, liver, kidney, brain and other vital organs can not tolerate surgery; 13. Those who had a birth plan during the trial and within 1 year after the completion of the trial, or the subjects and their spouses did not agree to take strict contraceptive measures during the trial and within 6 months after the completion of the trial (using condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc.); 14. Pregnant or lactating female subjects; 15. Subjects with poor compliance or other factors deemed unsuitable for participation in the study by the investigator.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 428, 'type': 'ESTIMATED'}}

2024-05-16