Clinical Study of 18F-Alfatide Injection PET/CT

NCT ID: NCT06416852

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 428 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2026-12-31

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.

Conditions

Non-Small Cell Lung Cancer NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

18F-Alfatide Injection

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yantai LNC Biotechnology Singapore PTE. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wuhan Union Hospital

Wuhan, , China

Countries

China

Facility Contacts

PI has not yet been identified

Role: primary

Other Identifiers

18F-Alfatide-003

Identifier Type: -

Identifier Source: org_study_id