NCT06183554招募中不适用
CXCR4 Targeted PET Imaging in the Diagnosis and Identification of Primary Aldosteronism
Xiao Chen1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年8月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Standardised uptake values
研究概览
简要总结
This study aimed to prospectively evaluate the utility of C-X-C chemokine receptor type 4 (CXCR4) positron emission tomography (PET) imaging in patients with clinical suspected primary aldosteronism (PA), with postoperative pathological or follow-up results as reference standards.
详细描述
- Record the course of disease, the laboratory examination (e.g., potassium, aldosterone, aldosterone-to-renin ratio, intravenous salt-loading test or captopril test) and the results of adrenal vein sampling in patients with clinically suspected PA.
- PET image analysis: Record and evaluate the following indicators: the maximum standardized uptake value (SUVmax) of lesions, the mean standardized uptake value (SUVmean) of normal liver, the SUVmean of adjacent normal adrenal tissue, the ratio of the lesional SUVmax to the normal liver SUVmean (LLR), and the ratio of the lesional SUVmax to the adjacent adrenal tissue SUVmean (LAR).
- Pathological analysis: Hematoxylin and eosin staining and immunohistochemical analyses will be performed. Immunohistochemical analysis will be used to investigate the expression of aldosterone synthase (CYP11B2) and CXCR4.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Persistent hypertension with blood pressure > 150/100 mmHg, refractory hypertension (blood pressure >140/90 mmHg with combined use of three types of antihypertensive medications, including diuretics), or with hypokalemia of blood pressure >140/90 mmHg;
- •Refractory hypertension with an aldosterone-to-renin ratio (ARR) ≥ 2.0 (ng/dl)/(mU/L);
- •Positive intravenous salt-loading test or captopril test;
- •Hypertension and adrenal lesions;
- •Patient ≥18 years of age at the time of consent;
- •Provided written informed consent authorisation before participating in the study.
排除标准
- •Refusal by the patients to undergo CXCR4 PET imaging, adrenal vein sampling, superselective adrenal arterial embolization or adrenalectomy;
- •Suspicion of familial hyperaldosteronism type 1 (FH-1) or type 3 (FH-3)；
- •Suspicion of adrenocortical carcinoma；
- •Severe comorbidity potentially interfering with treatment or HRQoL；
- •Requirement of medication interfering with the study protocol；
- •Pregnancy or lactation；
- •Estimated glomerular filtration rate <40 mL/min/1.73 m².
结局指标
主要结局
Standardised uptake values
时间窗: completed within one week after the PET examination
Standardised uptake values of suspected adrenal disease in CXCR4 PET imaging
次要结局
- Immunohistochemical results(completed within one week after surgery)
研究者
Xiao Chen
Director of Nuclear Medicine Department
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
研究点 (1)
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