A Single Center Study on the Evaluation of Diagnostic Efficacy of CXCR4 Targeted PET Imaging in Primary Aldosteronism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- renin
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of CXCR4 targeted PET imaging in preoperative localization diagnosis of primary aldosteronism (PA). Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET, and then underwent adrenal venous sampling (AVS). Then, the responsible adrenal adenoma will be resected by adrenalectomy, and examined with pathological section and staining. Researchers will compare the sensitivity and specificity between 68Ga-PentixaFor PET imaging and AVS in preoperative localization diagnosis of PA.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PA, confirmed by an elevated aldosterone/renin ratio (ARR) and an intravenous salt loading test.
- •The patient has provided written informed consent authorisation before participating in the study.
- •The patient is 18 to 70 years of age at the time of consent.
排除标准
- •Refusal by the patients to undergo 68Ga-PentixaFor PET/CT, AVS, CT, 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 health-related quality of life.
- •Patients need to take drugs that interfere with clinical research.
- •Any medical condition present that in the opinion of the investigator will affect patients clinical status.
- •Pregnancy or lactation.
- •Estimated glomerular filtration rate <40mL/min/1.73m
- •Interfering treatment in between 68Ga-PentixaFor PET/CT and AVS.
结局指标
主要结局
renin
时间窗: immediately after admission
measure the level of renin in blood
aldosterone
时间窗: immediately after admission
measure the level of aldosterone in blood
negative predictive value, NPV
时间窗: immediately after pathological examination
the NPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
SUVmax
时间窗: immediately after 68Ga-PentixaFor PET imaging
measure the maximum standardized uptake value of adrenal adenoma, liver, and lateral normal adrenal
positive predictive value,PPV
时间窗: immediately after pathological examination
the PPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
sensitivity
时间窗: immediately after pathological examination
the sensitivity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
specificity
时间窗: immediately after pathological examination
the specificity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA
次要结局
未报告次要终点