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

September 9, 2026 updated by: Edith Chow, Chinese University of Hong Kong
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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MTO-PET
Participant will receive [11C]metomidate PET-CT as the first lateralisation procedure
Procedure: [11C] Metomidate PETCT
Metomidate labelled with C11H3([11C]Metomidate) is used as a radiotracer in PET-CT to detect expression of CYP11B1 and CYP11B2 in adrenal cortex.
Active Comparator: Usual Care
Participants will receive adrenal venous sampling as per usual care as his/her first lateralisation strategy
Procedure: Adrenal Venous Sampling
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

September 5, 2026

First Submitted That Met QC Criteria

September 5, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026.106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Electronic medical record data from the public healthcare system in Hong Kong is owned by the Hospital Authority. Sharing of individual participant data that involves these records would require prior approval from the Hospital Authority and is subject to local regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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