[11C]Metomidate PET-CT vs Usual Care for People With Primary Aldosteronism: a Proof-of-concept Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Proportion of people who achieved complete or partial clinical success
研究概览
简要总结
The goal of this randomised open-label controlled study is to compare the biochemical and clinical responses following [11C]Metomidate-PET CT(MTO-PET) versus usual care with adrenal venous sampling as first lateralisation strategy in people with biochemically confirmed primary aldosteronism(PA). The main question it aims to answer is: what is the proportion of people who achieved complete or partial clinical success among those who underwent PA treatment?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PA made based on Endocrine Society guidelines:
- •Participants should demonstrate a positive screening test for primary aldosteronism, defined as:
- •Paired measurement of renin and aldosterone demonstrating a raised aldosterone-to-renin ratio >550 pmol/L/ng/mL/h AND
- •Suppressed renin <=1ng/ml/h
- •AND participants should demonstrate autonomous aldosterone secretion following salt-loading confirmatory tests, defined as:
- •1) Non-suppressed aldosterone >162pmol/L following seated saline infusion OR
- •2) raised 24-hour urine aldosterone >38 nmol/d following oral salt loading test (17)
- •For participants with spontaneous hypokalemia with renin below detection level and plasma aldosterone > 416 pmol/L(by LC-MS) at screening, the above confirmatory tests can be omitted due to high pre-test probability as proposed by latest guidelines (10).
- •Adrenal nodule on CT
排除标准
- •Unable to give informed consent
- •Participants who neither agree to AVS nor MTO-PET
- •Patients who indicate they will not proceed to adrenalectomy
- •Patients contraindicated for mineralocorticoid receptor antagonists
- •Patients who are unable/unwilling or contraindicated for dexamethasone required for MTO-PET
- •Estimated GFR < 30 ml/min/1.73m2
- •Any illness or condition that is considered unfit for study by the investigators
研究组 & 干预措施
MTO-PET
Participant will receive [11C]metomidate PET-CT as the first lateralisation procedure
干预措施: [11C] Metomidate PETCT (Procedure)
Usual Care
Participants will receive adrenal venous sampling as per usual care as his/her first lateralisation strategy
干预措施: Adrenal Venous Sampling (Procedure)
结局指标
主要结局
Proportion of people who achieved complete or partial clinical success
时间窗: at 6 and 12 months
Clinical success is defined by Primary Aldosteronism Surgical Outcome criteria for people who underwent surgery and Primary Aldosteronism Medical Treatment Outcome criteria for those who received mineralocorticoid receptor antagonist
Compare the proportion of people who achieved complete or partial clinical success
时间窗: at 6 and 12 months
Clinical success is defined by Primary Aldosteronism Surgical Outcome criteria for people who underwent surgery and Primary Aldosteronism Medical Treatment Outcome criteria for those who received mineralocorticoid receptor antagonist
次要结局
未报告次要终点
研究者
Edith Chow
Assistant Professor (Clinical)
Chinese University of Hong Kong