68Ga-Pentixafor PET/CT in the Diagnosis of Primary Aldosteronism and Pre-postoperative of Superselective Adrenal Artery Embolization
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
- Standardized uptake value (SUV)
研究概览
简要总结
Primary aldosteronism is the most common cause of secondary hypertension. The two main types of primary aldosteronism are aldosteronoma(30%) and adrenal hyperplasia(60%). The gold standard that determines the diagnosis and treatment strategy of primary aldosteronism is adrenal vein sampling(AVS), but the success rate is only about 80%. Using CXCR4 as a probe for 68Ga-Pentixafor PET/CT imaging can guide the classification diagnosis and treatment strategy of primary aldosteronism, which is a favorable supplement to AVS. Superselective adrenal artery embolization(SAAE) and laparoscopy are the main operation treatments for primary aldosteronism. SAAE is an invasive interventional operation. It is a novel way to evaluate the changes in the structure and function of adrenal tissue pre-postoperative SAAE by using the changes in 68Ga-Pentixafor PET/CT imaging.
详细描述
Primary aldosteronism: Hypertension is divided into primary hypertension and secondary hypertension. Secondary hypertension refers to hypertension with clear etiology. When the etiology is identified and effectively removed or controlled, hypertension as a secondary symptom can be cured or significantly relieved. The most common secondary hypertension is primary aldosteronism. Primary aldosteronism is due to excessive aldosterone secretion in the adrenal cortex, characterized by clinical syndromes of hyperaldosteronism, low renin activity, hypertension and hypokalemia. Compared with essential hypertension, the risk of cardiovascular and cerebrovascular events and the risk of target organ damage in patients with primary aldosteronism were significantly increased. On the contrary, early detection and treatment mean better blood pressure control, lighter target organ damage and better clinical outcomes. The two main types of primary aldosteronism are aldosteronoma(30%) and adrenal hyperplasia(60%). The gold standard that determines the diagnosis and treatment strategy of primary aldosteronism is adrenal vein sampling (AVS), but the success rate is only about 80 %. Therefore, it is necessary to explore a non-invasive examination method as a beneficial supplement to AVS.
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
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult population (aged 18 years or order);
- •patients with suspected or new diagnosed Primary aldosteronism (supporting evidence may include MRI, CT, laboratory tests);
- •patients who had scheduled 68Ga-BNU-PSMA PET/CT scan;
- •patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee;
- •healthy volunteers(aged 18 years or order).
排除标准
- •patients with pregnancy;
- •the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
研究组 & 干预措施
68Ga-Pentixafor
Each subject receive a single intravenous injection of 68Ga-Pentixafor, and undergo PET/CT imaging within the specificed time
干预措施: 68Ga-Pentixafor (Diagnostic Test)
结局指标
主要结局
Standardized uptake value (SUV)
时间窗: through study completion,an average of 3 years
Standardized uptake value (SUV) of 68Ga-Pentixafor for each target or suspected lesion of subject.
次要结局
- SAAE treatment evaluation(through study completion,an average of 3 years)
研究者
Weibing Miao, PhD
Director, Department of Nuclear Medicine
First Affiliated Hospital of Fujian Medical University