Primary AldosteronismNCT07814105
[11C]Metomidate PET-CT vs Usual Care for People With Primary Aldosteronism: a Proof-of-concept Study
A study testing [11C] Metomidate PETCT and Adrenal Venous Sampling in people with Primary Aldosteronism, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- [11C] Metomidate PETCT and Adrenal Venous Sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2026to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Shatin
About this 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?
- Conditions
- Primary Aldosteronism
- Being tested
- [11C] Metomidate PETCT, Adrenal Venous Sampling
- Keywords
- primary aldosteronism, metomidate, adrenal venous sampling
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C] Metomidate PETCTProcedure or surgery
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 SamplingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| MTO-PET | Experimental | Participant will receive [11C]metomidate PET-CT as the first lateralisation procedure Receives: Procedure: [11C] Metomidate PETCT |
| Usual Care | Active comparator | Participants will receive adrenal venous sampling as per usual care as his/her first lateralisation strategy Receives: Procedure: Adrenal Venous Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edith Chow, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814105
- Sponsor's protocol ID
- 2026.106
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [11C]Metomidate PET-CT vs Usual Care for People With Primary Aldosteronism: a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT07814105
- Acronym / sponsor ID
- 2026.106
- Conditions
- Primary Aldosteronism
- Keywords
- primary aldosteronism, metomidate, adrenal venous sampling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTO-PET | Experimental | Procedure: [11C] Metomidate PETCTParticipant will receive [11C]metomidate PET-CT as the first lateralisation procedure |
| Usual Care | Active comparator | Procedure: Adrenal Venous SamplingParticipants will receive adrenal venous sampling as per usual care as his/her first lateralisation strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of PA made based on Endocrine Society guidelines:
- Participants should demonstrate a positive screening test for primary aldosteronism, defined as:
- AND participants should demonstrate autonomous aldosterone secretion following salt-loading confirmatory tests, defined as:
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C] Metomidate PETCTMetomidate labelled with C11H3([11C]Metomidate) is used as a radiotracer in PET-CT to detect expression of CYP11B1 and CYP11B2 in adrenal cortex. | Procedure or surgery | MTO-PET |
| Adrenal Venous SamplingAdrenal 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. | Procedure or surgery | Usual Care |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [11C] Metomidate PETCT and Adrenal Venous Sampling in people with Primary Aldosteronism, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edith WK Chow, MBChB (+85235051601, edithwkchow@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the proportion of people who achieved complete or partial clinical success (time frame: at 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.