Clinical Study of 18F-Alfatide Injection PET/CT

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Sensitivity and specificity evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT [Срок оценки: Through study completion, assessed up to 2 years]

Вторичные конечные точки (2)

• Accuracy, positive predictive value and negative predictive value evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT [Срок оценки: Through study completion, assessed up to 2 years]
• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: Through study completion, assessed up to 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;
• 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.);
• Pregnant or lactating female subjects;
• Subjects with poor compliance or other factors deemed unsuitable for participation in the study by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Wuhan Union Hospital — Ухань

Идентификаторы

NCT: NCT06416852 · 18F-Alfatide-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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