clinical study of 18f-alfatide injection pet/ct

Conditions: Non-Small Cell Lung Cancer NSCLC

Summary: 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.


Eligibility criteria:
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 \&gt; 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 \&lt;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.