Clinical Study of 18F-Alfatide Injection PET/CT

Yantai LNC Biotechnology

Status and phase: Not yet enrolling; Phase 3

Conditions: Non-Small Cell Lung Cancer NSCLC

Treatments: Drug: 18F-FDG Injection; Drug: 18F-Alfatide Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06416852

18F-Alfatide-003

Details and patient eligibility

About

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.

Enrollment: 428 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

428 participants in 1 patient group

18F-Alfatide and 18F-FDG Injection

Experimental group

Description:

The study is designed as a self-controlled trial, in which participants will be injected and scanned with two drugs.

Treatment:

Drug: 18F-FDG Injection

Drug: 18F-Alfatide Injection