Clinical Study of 18F-Alfatide Injection PET/CT

Trial Title: Clinical Study of 18F-Alfatide Injection PET/CT

NCT ID: NCT06416852

Condition: Non-Small Cell Lung Cancer NSCLC

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Fluorodeoxyglucose F18

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 18F-Alfatide Injection
Description: 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.
Arm group label: 18F-Alfatide and 18F-FDG Injection

Intervention type: Drug
Intervention name: 18F-FDG Injection
Description: 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.
Arm group label: 18F-Alfatide and 18F-FDG Injection

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.

Criteria for 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 > 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Wuhan Union Hospital

Address:
City: Wuhan
Zip: 430000
Country: China

Contact:
Last name: PI has not yet been identified

Start date: August 2024

Completion date: December 2026

Lead sponsor:
Agency: Yantai LNC Biotechnology Singapore PTE. LTD.
Agency class: Industry

Source: Yantai LNC Biotechnology Singapore PTE. LTD.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06416852