Imaging Characteristics of Different ⁶⁸Ga-PSMA Probes in Prostate Cancer

Официальное название

Comparative Study on Imaging Characteristics of Different ⁶⁸Ga-Labeled PSMA Probes in Patients With Prostate Cancer

Обзор

This study aims to evaluate the imaging characteristics of \[⁶⁸Ga\]Ga-GS24-B2-250-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-250-T), \[⁶⁸Ga\]Ga-GS24-B2-268-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-268-T), \[⁶⁸Ga\]Ga-GS24-B2-237-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-237-T), and \[⁶⁸Ga\]Ga-PSMA-11 Injection (abbreviated as ⁶⁸Ga-PSMA-11) as PET/CT imaging agents in patients with prostate cancer.

Вмешательства

• Диагностический тест 68Ga-GS24-B2-268-T
  detect prostate cancer lesions via 68Ga-GS24-B2-268-T PET/CT imaging
• Диагностический тест 68Ga-GS24-B2-250-T
  detect prostate cancer lesions via 68Ga-GS24-B2-250-T PET/CT imaging
• Диагностический тест 68Ga-GS24-B2-237-T
  detect prostate cancer lesions via 68Ga-GS24-B2-237-T PET/CT imaging
• Диагностический тест 68Ga-PSMA-11
  detect prostate cancer lesions via 68Ga-PSMA-11 PET/CT imaging

Первичные конечные точки

• Standardized Uptake Value for major organs (salivary glands, kidneys, bone marrow, etc.) and tumor lesions (primary and metastatic lesions) [Срок оценки: 5 days]

Критерии участия

Критерии включения

• The subject has fully understood the trial content, process, and potential risks, and has voluntarily signed the informed consent form;
• Male subjects aged ≥ 18 years;
• Clinically or radiologically assessed as metastatic hormone-sensitive prostate cancer (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC);
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• Presence of positive lesions on ⁶⁸Ga-PSMA-11 PET/CT scan;
• Blood routine, renal function, and liver function tests meeting the following criteria:

• Platelet count > 90 × 10⁹/L;
• Urea/urea nitrogen and serum creatinine < 1.5 × upper limit of normal (ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 × ULN;
• Expected survival time ≥ 6 months;
• From the date of signing the informed consent form until 3 months after administration, the subject and his partner must use effective contraceptive measures, and the subject must avoid sperm donation.

Критерии исключения

• Having participated in another interventional clinical trial prior to signing the informed consent form and being within 5 half-lives of the investigational product of that trial; or currently participating in another interventional clinical trial; or having participated in a clinical trial involving radiopharmaceuticals prior to signing the informed consent form with an interval of less than 3 months between the last dose and the informed consent signing date.
• Having received any intravenous iodine-containing contrast agent within 24 hours prior to administration, or any high-density oral contrast agent (e.g., barium sulfate) within 5 days prior to administration. Oral water-soluble contrast agents (e.g., compound meglumine diatrizoate oral solution) are acceptable.
• Having received high-energy γ-ray-emitting agents (>300 KeV, e.g., radiopharmaceuticals labeled with radionuclides such as \[¹³¹I\]I, \[¹⁸F\]F, \[⁶⁸Ga\]Ga, \[⁶⁴Cu\]Cu, etc.) within a period equivalent to either 5 half-lives of the agent or 2 days, whichever is longer, prior to administration.
• Planning to adjust anti-tumor medication during the study period.
• Being unable to complete the required PET/CT imaging procedures.
• Having any medical condition or other circumstances that, in the investigator's judgment, may affect the safety or compliance of the subject.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07365397 · GenSciP153-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗