Clinical Study of 18F-Alfatide Injection PET/CT

NCT06416852 | Not Yet Recruiting Phase 3

• 1 other identifier: 18F-Alfatide-003
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Accuracy, positive predictive value and negative predictive value evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT

  Through study completion, assessed up to 2 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Through study completion, assessed up to 2 years

Study Arms (1)

18F-Alfatide and 18F-FDG Injection

EXPERIMENTAL

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

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

Interventions

18F-Alfatide Injection 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-Alfatide and 18F-FDG Injection

18F-FDG Injection 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.

18F-Alfatide and 18F-FDG Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects understand the clinical trial procedure and sign the informed consent in person;
• 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;
• Over 18 years old (including 18 years old);
• ECOG function status score 0\~1 points ;
• Expected survival \> 3 months.

You may not qualify if:

• Known allergic history to 18F-Alfatide Injection and 18F-FDG injection or its excipients;
• Patients who cannot tolerate intravenous drug administration (such as needle fainting and blood fainting history);
• Patients who are not suitable for PET or cannot complete PET or other imaging tests due to special reasons, including claustrophobia and radiophobia;
• Workers who need to be exposed to radioactive conditions for a long time;
• 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;
• Fasting blood glucose level more than 7.0 mmol/L;
• There are serious infections that cannot be controlled before screening;
• 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.;
• 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.
• Participants who had participated in clinical trials of radiopharmaceuticals within 1 year before screening;
• Participating in other interventional clinical trials within 1 month before screening;
• Poor general condition, heart, lung, liver, kidney, brain and other vital organs can not tolerate surgery;

Sponsors & Collaborators

• Yantai LNC Biotechnology Singapore PTE. LTD.: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, 430000, China

Location

MeSH Terms

Interventions

alfatide II; Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 16, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)