Clinical Study of 18F-Alfatide Injection PET/CT

Non-Small Cell Lung Cancer NSCLC Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416852
• Other study ID #: 18F-Alfatide-003
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Yantai LNC Biotechnology Singapore PTE. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 428
• Est. completion date: December 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer NSCLC

Intervention

Drug:
• 18F-Alfatide Injection
A single dose of (0.1~0.15)±0.015 mCi/kg IV injection of 18F-Alfatide. The patients will be intravenously injected with 18F-Alfatide Injection and undergo PET/CT scan at 60 min±10 min after the injection.
• 18F-FDG Injection
A single dose of 5~10mCi IV injection of 18F-FDG. The patients will be intravenously injected with 18F-FDG Injection and undergo PET/CT scan at 40 min±10 min after the injection.

Locations

Country	Name	City	State
China	Wuhan Union Hospital	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Yantai LNC Biotechnology Singapore PTE. LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT	To evaluate the sensitivity and specificity of 18F-Alfatide Injection PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer compared with 18F-FDG PET/CT.All subjects in this study underwent 18F-Alfatide PET-CT and 18F-FDG PET-CT examination within one week, radical surgery and lymph node dissection within two weeks after the completion of the two scanning images, and pathological examination of the obtained lymph nodes was used as the gold standard.	Through study completion, assessed up to 2 years
Secondary	Accuracy, positive predictive value and negative predictive value evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT	To evaluate the accuracy, positive predictive value and negative predictive value of 18F-Alfatide Injection PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer compared with 18F-FDG PET/CT.All subjects in this study underwent 18F-Alfatide PET-CT and 18F-FDG PET-CT examination within one week, radical surgery and lymph node dissection within two weeks after the completion of the two scanning images, and pathological examination of the obtained lymph nodes was used as the gold standard	Through study completion, assessed up to 2 years
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	To evaluate the safety of 18F-Alfatide Injection PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer compared with 18F-FDG PET/CT.The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.	Through study completion, assessed up to 2 years