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[11C]Metomidate PET-CT vs Usual Care for People With Primary Aldosteronism: a Proof-of-concept Study

RecruitingNAAges 18 Years - anyAllChinese University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

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?

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 * For participants with spontaneous hypokalemia with renin \<0.2ng/ml/h 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 . * Adrenal nodule on CT Exclusion Criteria: * 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
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What it tests

  • [11C] Metomidate PETCT
  • Adrenal Venous Sampling
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Where

1 site
Chinese University of Hong Kong
Shatin, Hong Kong
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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