Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors

Официальное название

A Prospective Clinical Study of an EpCAM-Targeted Radiotracer for Molecular Imaging of Epithelial Tumors

Обзор

The goal of this prospective, single-arm clinical trial is to evaluate the imaging performance and safety of an EpCAM-targeted radiotracer, \[68Ga\]Ga-PN-EpC1, in patients with epithelial tumors. The main questions it aims to answer are: * What is the sensitivity of \[68Ga\]Ga-PN-EpC1 PET/CT for detecting EpCAM-positive tumor lesions? * How does the radiotracer uptake correlate with EpCAM expression assessed by immunohistochemistry? * Is \[68Ga\]Ga-PN-EpC1 safe and well tolerated when administered for PET/CT imaging in patients with epithelial tumors? Participants will undergo \[68Ga\]Ga-PN-EpC1 PET/CT imaging prior to tumor biopsy or surgical resection. Imaging findings will be analyzed and compared with histopathological results and standard imaging assessments. Safety will be evaluated by monitoring adverse events following radiotracer administration.

Вмешательства

• Диагностический тест [68Ga]Ga-PN-EpC1 PET/CT
  Participants will receive a single intravenous administration of the EpCAM-targeted radiotracer \[68Ga\]Ga-PN-EpC1 for PET/CT imaging. The radiotracer will be administered at a dose of 0.05-0.1 mCi/kg, followed by whole-body PET/CT acquisition according to the study imaging protocol. Additional dynamic or delayed imaging may be performed in selected participants.

Первичные конечные точки

• Sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for lesion detection [Срок оценки: From PET/CT imaging to histopathological confirmation within 2 months.]

Вторичные конечные точки (3)

• Specificity and Accuracy of [68Ga]Ga-PN-EpC1 PET/CT for Lesion Detection [Срок оценки: From PET/CT imaging to histopathological confirmation within 2 months.]
• Correlation Between [68Ga]Ga-PN-EpC1 Uptake and EpCAM Expression Levels [Срок оценки: From PET/CT imaging to IHC analysis of biopsy or surgical specimens (within 2 months).]
• Safety of [68Ga]Ga-PN-EpC1 PET/CT Imaging [Срок оценки: Within 72 hours post-injection of [68Ga]Ga-PN-EpC1.]

Критерии участия

Критерии включения

• Patients with diagnosed or suspected tumors visiting the hospital between January 2026 and December 2026, who are scheduled for pathological biopsy or surgical treatment within 2 months.
• Age > 18 years, regardless of gender.
• Adequate organ and bone marrow function as defined by the following laboratory values:

• Hematology: WBC ≥4.0×10\^9/L or ANC ≥1.5×10\^9/L; PLT ≥100×10\^9/L; Hemoglobin ≥90 g/L.
• Liver Function: Total bilirubin ≤1.5× ULN; ALT and AST ≤2.5× ULN (or ≤5× ULN if liver metastases are present).
• Renal Function: BUN ≤1.5× ULN; Serum Creatinine (SCr) ≤1.5× ULN.
• Normal cardiac function.
• Expected life expectancy ≥12 weeks.
• Presence of at least one measurable target lesion according to RECIST v1.1 criteria.
• Patients recommended by clinicians to undergo PET/CT examination for tumor diagnosis and staging.
• Women of childbearing potential must have a negative pregnancy test within 7 days prior to the examination. Male and female patients of reproductive age must agree to use effective contraception during the study and for at least 3 months after the examination.
• Voluntarily participate in the study, demonstrate full understanding of the protocol, and provide written informed consent.

Критерии исключения

• Severe laboratory abnormalities, including significant impairment of hepatic or renal function, or severe hematological dysfunction.
• History of allergic diseases.
• Patients planning for pregnancy during the study period.
• Pregnant or lactating women.
• Inability to maintain a supine position for at least 30 minutes.
• Patients with claustrophobia or other diagnosed psychiatric disorders that may interfere with compliance.
• Any other condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the evaluation of the study results.

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

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07400263 · 2025PHB625

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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