Clinical Study of 18F-Alfatide Injection PET/CT

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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Small Cell Lung Cancer NSCLC
• Intervention / Treatment: Drug: 18F-Alfatide Injection; Drug: 18F-FDG Injection

• Study Type: Interventional
• Enrollment (Estimated): 428
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Wuhan, China, 430000
    • Wuhan Union Hospital
    • Contact: PI has not yet been identified

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 18F-Alfatide and 18F-FDG Injection; The study is designed as a self-controlled trial, in which participants will be injected and scanned with two drugs.

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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Yantai LNC Biotechnology Singapore PTE. LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 18F-Alfatide-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No