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RecruitingNCT07814105Updated Oct 26, 2026

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

An interventional study of [11C] Metomidate PETCT and Adrenal Venous Sampling in Primary Aldosteronism, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Other

Updated Oct 26, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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?

02

Conditions studied

  • Primary Aldosteronism

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Keywords

  • primary aldosteronism
  • metomidate
  • adrenal venous sampling
03

In context

Hyperaldosteronism

201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.

This study's planned enrollment of 32 is below the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.

Browse Hyperaldosteronism studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 26, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Unable to give
  • Participants who neither agree to AVS nor MTO-PET
  • Patients who indicate they will not proceed to adrenalectomy
  • Patients for mineralocorticoid receptor antagonists
  • Patients who are unable/unwilling or contraindicated for dexamethasone required for MTO-PET
  • Estimated \< 30 ml/min/1.73m2
  • Any illness or condition that is considered unfit for study by the investigators
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    MTO-PET

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

    Procedure: [11C] Metomidate PETCT

  • Active comparator
    Usual Care

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

    Procedure: Adrenal Venous Sampling

Interventions

  • 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.

  • ProcedureAdrenal 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.

06

What researchers measure

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

    Time frame: at 6 and 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Sep 2030, 46 months later.

Of 35 interventional studies with no phase under Hyperaldosteronism, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 46 months is above that.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 26, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2026
First posted
Sep 10, 2026
StartEst.
Nov 1, 2026was Oct 2026
Primary completionEst.
Sep 2030
CompletionEst.
Sep 2030
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 26, 2026
Sites
Chinese University of Hong Kong is now Recruiting
Oct 26, 2026
Start date
Oct 1, 2026→Nov 1, 2026
Oct 26, 2026
Eligibility
Minimum age 19 Years→18 Years; 2 inclusion criteria edited
What changed in the criteria
Inclusion criteria
  • Edited2) raised 24-hour urine aldosterone >38 nmol/d following oral salt loading test (17)
  • EditedFor participants with spontaneous hypokalemia with renin below detection level<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 (10).
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Not yet recruiting→Recruiting
    Chinese University of Hong Kong is now Recruiting
    Start date Oct 1, 2026→Nov 1, 2026
    Eligibility Minimum age 19 Years→18 Years; 2 inclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • Edited2) raised 24-hour urine aldosterone >38 nmol/d following oral salt loading test (17)
    • EditedFor participants with spontaneous hypokalemia with renin below detection level<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 (10).
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07814105
Responsible party
Edith Chow (Assistant Professor (Clinical), Chinese University of Hong Kong) — Principal investigator
First posted
Sep 10, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Sep 2030 (estimated)
Completion
Sep 2030 (estimated)
Last update
Oct 26, 2026

Study contacts

Edith WK Chow, MBChB
Contact
edithwkchow@cuhk.edu.hk
+85235051601

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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