Clinical trial NCT06416852: Clinical Study of 18F-Alfatide Injection PET/CT
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer NSCLC
Lead sponsor: Yantai LNC Biotechnology Singapore PTE. LTD.
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Primary outcomes:
measure: Sensitivity and specificity evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT
timeFrame: Through study completion, assessed up to 2 years
Secondary outcomes:
measure: Accuracy, positive predictive value and negative predictive value evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT
timeFrame: Through study completion, assessed up to 2 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Through study completion, assessed up to 2 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
Study officials:
References: