Clinical Study of 18F-Alfatide Injection PET/CT

Prior treatment

• Patients who cannot tolerate intravenous drug administration (such as needle fainting and blood fainting history);
• 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.
• Participating in other interventional clinical trials within 1 month before screening;
• 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.);

Other illness

• Known allergic history to 18F-Alfatide Injection and 18F-FDG injection or its excipients;
• Workers who need to be exposed to radioactive conditions for a long time;
• There are serious infections that cannot be controlled before screening;
• 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.;
• Poor general condition, heart, lung, liver, kidney, brain and other vital organs can not tolerate surgery;

Lab values

• 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;
• Fasting blood glucose level more than 7.0 mmol/L;

Other

• Patients who are not suitable for PET or cannot complete PET or other imaging tests due to special reasons, including claustrophobia and radiophobia;
• Participants who had participated in clinical trials of radiopharmaceuticals within 1 year before screening;
• Pregnant or lactating female subjects;
• Subjects with poor compliance or other factors deemed unsuitable for participation in the study by the investigator.

• The subjects understand the clinical trial procedure and sign the informed consent in person;
• 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;
• Over 18 years old (including 18 years old);
• ECOG function status score 0\~1 points ;
• Expected survival \> 3 months.