Clinical Study of Glypican-3 (GPC3)-Targeted Novel Probe 18F-X12 for the Diagnosis of Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events [Safety and Tolerability]
研究概览
简要总结
This is a diagnostic study. This clinical trial aims to evaluate the diagnostic performance and safety of the novel radiotracer 18F-X12 in patients with hepatocellular carcinoma (HCC), and to provide evidence supporting a new approach for its early diagnosis, accurate staging and recurrence assessment.
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
- 是
入选标准
- •Patients aged ≥ 18 years old.
- •Patients fully understand the trial requirements, participate in the study voluntarily, and provide written informed consent.
- •Meet either of the following two conditions:
- •Patients with highly suspected hepatocellular carcinoma (HCC) (hepatic space-occupying lesion of undetermined nature on imaging examination) or pathologically confirmed HCC, with no prior systemic therapy (including immunotherapy, chemoradiotherapy, targeted therapy, etc.) or suspected tumor recurrence after previous treatment, and able to independently cooperate with relevant examinations.
- •Patients with clinically diagnosed HCC who have received 18F-FDG positron emission tomography/computed tomography (PET/CT) for clinical staging or post-treatment restaging, and able to independently cooperate with relevant examinations.
排除标准
- •Patients with severe non-malignant diseases that may interfere with study objectives, or impair subject safety and study compliance, including but not limited to psychiatric disorders, infectious diseases, autoimmune diseases, and metabolic diseases.
- •Pregnant or lactating females.
- •Subjects who are unable to understand the examination procedure or cannot cooperate with trial-related examinations and operations.
研究组 & 干预措施
18F-X12 PET/CT
The objective is to evaluate the diagnostic efficacy and safety of the novel radiotracer 18F-X12 in patients with hepatocellular carcinoma (HCC).
干预措施: 18F-X12 PET/CT (Diagnostic Test)
结局指标
主要结局
Incidence of Adverse Events [Safety and Tolerability]
时间窗: 24 hours after the injection of 18F-X12
Clinical symptoms and adverse events (e.g., fever, rash, hypoglycemia) will be monitored within 24 hours after injection, and graded according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 6.0).
To evaluate the diagnostic efficacy of 18F-X12 PET/CT for hepatocellular carcinoma (HCC).
时间窗: From study completion to 1 month after completion
We calculated the diagnostic sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-X12 positron emission tomography (PET) imaging for patients with hepatocellular carcinoma (HCC), with histopathological results as the diagnostic gold-standard reference.
次要结局
- Standardized Uptake Values of Primary and Metastatic Lesions on ¹⁸F-X12 PET/CT versus ¹⁸F-FDG PET/CT(From the date of study completion up to 1-month post-completion)
- Correlation between 18F-X12 Uptake and GPC3 Pathological Expression(From the date of study completion up to 1-month post-completion)
研究者
Meng LIU
Chief Physician
Peking University First Hospital