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

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?

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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Endocrine System Diseases Hyperaldosteronism

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese University of Hong Kong

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (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

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

Treatment and study plan

[11C] Metomidate PETCT

Procedure

Metomidate labelled with C11H3([11C]Metomidate) is used as a radiotracer in PET-CT to detect expression of CYP11B1 and CYP11B2 in adrenal cortex.

adrenal venous sampling

Procedure

Adrenal venous sampling is an invasive procedure that involves insertion of a catheter to adrenal veins to determine if one side of the adrenal is producing excess aldosterone hormones compared to the other side.

Primary outcomes

Compare the proportion of people who achieved complete or partial clinical success

Time frame: 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

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Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Sep 10, 2026
Registry last updated: Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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