NCT07814105

Brief Summary

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?

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
48mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

3.9 years

First QC Date

September 5, 2026

Last Update Submit

September 9, 2026

Conditions

Primary Aldosteronism

Keywords

primary aldosteronismmetomidateadrenal venous sampling

Outcome Measures

Primary Outcomes (1)

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

    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

Study Arms (2)

MTO-PET

EXPERIMENTAL

Participant will receive \[11C\]metomidate PET-CT as the first lateralisation procedure

Procedure: [11C] Metomidate PETCT

Usual Care

ACTIVE COMPARATOR

Participants will receive adrenal venous sampling as per usual care as his/her first lateralisation strategy

Procedure: Adrenal Venous Sampling

Interventions

[11C] Metomidate PETCTPROCEDURE

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

MTO-PET
Adrenal Venous SamplingPROCEDURE

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.

Usual Care

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • \) Non-suppressed aldosterone \>162pmol/L following seated saline infusion OR
  • \) 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Central Study Contacts

Edith WK Chow, MBChB

CONTACT

+85235051601edithwkchow@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Clinical)

Study Record Dates

First Submitted

September 5, 2026

First Posted

September 10, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

HK(1)