Non-small cell lung cancer
Conditions
Interventions
Control group:18F-FDG PET/CT
Experimental group:99mTc-CNDG7 SPECT/CT Diagnosis
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the clinical trial, sign the informed consent form, and be willing and able to comply with all trial procedures; 2.Aged from 18 to 75 years old (inclusive), with no restriction on gender; 3.Meet any one of the following criteria: Previously pathologically diagnosed with NSCLC; Highly suspected of having NSCLC based on clinical and imaging evaluation; 4.Imaging examination shows lymph nodes with a short diameter greater than 1 cm, and radical surgery (including systematic lymph node dissection) is scheduled to be performed within 14 days after the imaging examination; 5.Imaging evaluation reveals solid nodules or mixed-density nodules with a long diameter of 2 cm or above; 6.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 7.Patients with an expected survival time of >= 6 months; 8.Possess adequate organ function; Platelet count > 100×10^9/L; Blood urea nitrogen and serum creatinine < 1.5 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times ULN; 9.Trial participants (including their partners) have no plans for childbearing, sperm donation or egg donation from the signing of the informed consent form to 6 months after the administration of the trial drug, and voluntarily abide by the specified contraceptive requirements;
Exclusion criteria
Exclusion criteria: 1.Prior receipt of local or systemic anti-tumor treatments such as surgery or radiotherapy related to non-small cell lung cancer (NSCLC); 2.Having an allergic constitution (e.g., allergy to two or more drugs or foods) or known allergy to the components of the investigational drug; 3.Participation in other interventional clinical trials and receipt of drug/medical device treatment within 1 month prior to signing the informed consent form; 4.Fasting blood glucose level >11.1 mmol/L prior to the administration of the investigational drug; 5.Body weight >100 kg; 6.Inability to tolerate raising both arms and lying supine for 15 to 30 minutes; 7.Inability to accept or tolerate SPECT/CT, contrast-enhanced CT or PET/CT scans, or failure to comply with fasting and dietary control requirements; 8.Suffering from active infections requiring systemic treatment, inflammatory diseases or clinically significant autoimmune diseases within 14 days before the administration of the investigational drug; 9.Known medical history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome; 10.History of other malignant tumors within the past 5 years (excluding cured basal cell carcinoma of the skin or carcinoma in situ of the cervix); 11.Female trial participants who are pregnant or breastfeeding, or have a positive pregnancy test result during the screening period; 12.Having any medical conditions or other factors judged by the investigator to affect safety, compliance or the integrity of trial data, making them unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Accuracy;Positive predictive value and negative predictive value (lymph node grouping level); | — |
Countries
China
Contacts
Public ContactLi Huo
Peking Union Medical College Hospital
Outcome results
None listed