NCT06148155招募中不适用
A Study of [68Ga]Ga-NOTA-RG2 PET Imaging in the Diagnosis of Hepatocellular
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete PET imaging
研究概览
简要总结
The aim of this study was to establish and optimize the imaging method of [68Ga]Ga-NOTA-RG2, as well as its physiological and pathological distribution characteristics, and on this basis to evaluate the diagnostic efficacy of the above imaging agents in patients with hepatocellular carcinoma.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatocellular carcinoma patients
- •Age between 18 and 65 years old, gender is not limited.
- •Patients with suspicious intrahepatic spaces detected by MR and considered to be hepatocellular carcinoma with AFP>200 ug/L who have not undergone surgery.
- •Patients with hepatocellular carcinoma confirmed by puncture pathology
- •Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
- •Willingness and ability to cooperate with all programs of the study.
排除标准
- •Subjects meeting any of the following criteria will be excluded from the study:
- •Patients receiving anti-tumor therapy prior to the PET/CT scan.
- •Suffering from severe other neurological disorders, or gastrointestinal, cardiovascular, hepatic, renal, hematologic, respiratory, immunodeficiency, and other serious diseases.
- •Alternative subjects with conditions that contraindicate PET/CT scanning. This includes, but is not limited to, elevated blood glucose that is not effectively controlled; pregnant, lactating, or breastfeeding women; those who are unable to receive repeated intravenous injections; those who may be hypersensitive to the drug and its components (including a history of severe allergies or anaphylactic reactions, especially to the drug being examined); and hermetic phobias.
- •Within the past year, have participated in other research protocols or clinical care, in addition to the radiation exposure expected from participation in this clinical study, which has resulted in radiation exposure in excess of an effective dose of 50 mSv.
- •Alternative subjects have undergone major surgery within the last 3 months; experimental drug or device therapy (of uncertain efficacy or safety) within 1 month
- •The alternate subject has any clinical condition that, in the opinion of the Sponsor of this study, may cause or has the potential to cause harm from this agent.
研究组 & 干预措施
patients with primary and/or metastatic hepatocellular carcinoma (HCC)
Experimental
The diagnosis of HCC is established by surgery or biopsy pathology.
干预措施: [68Ga]Ga-NOTA-RG2 PET Imaging (Radiation)
结局指标
主要结局
Complete PET imaging
时间窗: 90mins from time of injection
To assess the sensitivity and specificity of diagnosing HCC using \[68Ga\]Ga-NOTA-RG2.
次要结局
未报告次要终点
研究者
研究点 (1)
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