Metomidate PET-CT vs Usual Care for Primary Aldosteronism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized open-label study compares a first-line imaging strategy using [11C]Metomidate PET-CT to the standard adrenal venous sampling approach in adults with biochemically confirmed primary aldosteronism. Participants are randomized to receive either the MET PET-CT guided strategy or usual care, with the goal of determining how many achieve complete or partial clinical success after PA-directed treatment. The trial focuses on biochemical and clinical responses following the chosen lateralization method for treatment decisions. Interventions include [11C] Metomidate PET-CT and adrenal venous sampling. Eligibility requires confirmed primary aldosteronism per Endocrine Society criteria and suitability for AVS with CT-confirmed adrenal nodules; key exclusions include inability to consent or AVS-related constraints.

Why it matters

Who can join: the full rules

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

Where it's running

• Chinese University of Hong Kong
  Shatin, Hong Kong Recruiting

Study contacts

• Study coordinator: Edith WK Chow, MBChB
• Email: edithwkchow@cuhk.edu.hk
• Phone: +85235051601

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.