NCT05131061已完成不适用
68Ga-Pentixafor PET/CT for the Subtyping Diagnosis of Primary Aldosteronism: A Prospective Diagnostic Accuracy Study
Qifu Li1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年11月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- accuracy of 68Ga-PentixaforPET/CT in subtyping diagnosis of PA
研究概览
简要总结
To evaluate the value of 68Ga-Pentixafor PET/CT in the diagnosis of primary aldosteronism subtype
详细描述
This is a prospective study. We will enroll 100 patients with definite diagnosis of PA using adrenal venous sampling(AVS) as the gold standard for subtype to evaluate the value of 68Ga-pentixaforPET/CT in the diagnosis of PA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PA diagnosis confirmed by at least one confirmatory test
- •willingness to undergo AVS and surgery
- •informed consent to participate in the study.
排除标准
- •PA patients who met guideline criteria for bypassing AVS [i.e. younger than 35 years old, with typical APA characteristics (plasma aldosterone >300pg/ml, plasma renin < 2·5mIU/l, serum potassium <3·5mmol/l, CT indicated unilateral 1cm low-density adenoma);
- •failed adrenal vein cannulation during AVS;
- •Subtyping diagnosis was inconclusive based on AVS results (e.g. aldosterone/cortisol ratio in bilateral adrenal veins lower than the peripheral vein, or missing data);
- •pregnant or lactating women;
- •patients with a history of uncontrolled malignant tumor;
- •concurrent Cushing's syndrome [including mild autonomous cortisol secretion: cortisol after 1mg dexamethasone suppression test (DST)>138 nmol/l or cortisol after 2mg DST >50 nmol/l or cortisol after 1mg DST 50-138 nmol/l plus adrenocorticotrophic hormone (ACTH)<10pg/ml;
- •diagnosis of familial hyperaldosteronism;
- •imaging characteristics suggestive of pheochromocytoma or adrenal cortical carcinoma;
- •unsuitable for surgery, such as heart failure with New York Heart Association (NYHA) class III or IV, severe anemia (Hemoglobin<60g/L), stroke or acute coronary syndrome within 3 months, severe ascites and cirrhosis, estimated glomerulus filtration rate<30ml/min/m;
- •alcohol or drug abuse and mental disorders.
结局指标
主要结局
accuracy of 68Ga-PentixaforPET/CT in subtyping diagnosis of PA
时间窗: at the end of study(the last enrolled patient completed a 3-month follow-up)
AUC
次要结局
未报告次要终点
研究者
Qifu Li
Primary investigator
Chongqing Medical University
研究点 (1)
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