NCT07400263尚未招募不适用
A Prospective Clinical Study of an EpCAM-Targeted Radiotracer for Molecular Imaging of Epithelial Tumors
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for lesion detection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
EpCAM PET
Experimental
干预措施: [68Ga]Ga-PN-EpC1 PET/CT (Diagnostic Test)
结局指标
主要结局
Sensitivity of [68Ga]Ga-PN-EpC1 PET/CT for lesion detection
时间窗: From PET/CT imaging to histopathological confirmation within 2 months.
Sensitivity of \[68Ga\]Ga-PN-EpC1 PET/CT for detecting epithelial tumor lesions, using histopathological results as the reference standard.
次要结局
- Specificity and Accuracy of [68Ga]Ga-PN-EpC1 PET/CT for Lesion Detection(From PET/CT imaging to histopathological confirmation within 2 months.)
- Correlation Between [68Ga]Ga-PN-EpC1 Uptake and EpCAM Expression Levels(From PET/CT imaging to IHC analysis of biopsy or surgical specimens (within 2 months).)
- Safety of [68Ga]Ga-PN-EpC1 PET/CT Imaging(Within 72 hours post-injection of [68Ga]Ga-PN-EpC1.)
研究者
Xing Yang
Professor
Peking University People's Hospital
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