A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer

Официальное название

A Clinical Study on the Safety and Tolerability, Biodistribution, Radiation Dosimetry, and Diagnostic Efficacy of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer

Обзор

Primary Objective: To evaluate the safety and tolerability of PET imaging following a single intravenous infusion of \[⁶⁸Ga\]Ga-ELI421 injection in patients with prostate cancer. Secondary Objectives: To evaluate the biodistribution characteristics of \[⁶⁸Ga\]Ga-ELI421 injection; To evaluate the radiation dosimetry characteristics of \[⁶⁸Ga\]Ga-ELI421 injection; To evaluate the diagnostic efficacy of PET imaging with \[⁶⁸Ga\]Ga-ELI421 injection.

Вмешательства

• Препарат [68Ga]Ga-ELI421 injection
  Administration Protocol: A single rapid intravenous bolus injection of \[68Ga\]Ga-ELI421 injection at a radioactivity dose of about 185 MBq (5 mCi), followed by catheter flushing with approximately 10 mL of 0.9% sterile normal saline. Static scanning and/or dynamic scanning Whole-body PET Imaging will be performed. PSMA PET imaging will be performed in accordance with routine clinical practice.

Первичные конечные точки

• Adverse Event (AE) [Срок оценки: Day1, Day2-3]

Вторичные конечные точки (3)

• Lesion uptake value [Срок оценки: Day1]
• Absorbed dose [Срок оценки: Day1]
• Diagnostic performance [Срок оценки: Day1]

Критерии участия

Критерии включения

• Has been fully informed about the study and voluntarily provided written informed consent prior to initiation of any study-related procedures;
• Aged ≥ 18 years;
• In generally good condition with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Patients with histopathologically and/or cytologically confirmed prostate cancer;
• Has an indication for PSMA PET imaging;
• No clinically significant abnormal findings on physical examination, vital signs, laboratory tests, 12-lead ECG, or other examinations that may compromise subject safety or imaging results.
• Subjects of reproductive potential agree to refrain from pregnancy, sperm donation, and voluntarily use highly effective contraceptive methods (including by their partner) for 6 months after study drug administration, such as condoms, oral or injectable contraceptives, intrauterine devices (IUDs), etc.

Критерии исключения

• Presence of comorbidities that may compromise subject safety or interfere with imaging results;
• Concomitant medications that may compromise subject safety or interfere with imaging results;
• Insufficient washout period following prior anti-tumor therapies (including cytotoxic chemotherapy, immunotherapy, radiotherapy, etc.), which may compromise subject safety or interfere with imaging results;
• Known hypersensitivity to ionizing radiation or alcohol, or hypersensitivity to \[⁶⁸Ga\]Ga-ELI421 injection or its excipients, or other history of severe allergic reactions;
• Inability to complete PET imaging as required;
• Any other conditions deemed inappropriate by the investigator for participation in this study.

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

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07689656 · Xlan-20260318

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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