NCT07814105 [11C]Metomidate PET-CT vs Usual Care for People With Primary Aldosteronism: a Proof-of-concept Study
| NCT ID | NCT07814105 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Primary Aldosteronism |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-11-01 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2026-11-01 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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?
Eligibility Criteria
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: * 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 & Investigator
Frequently Asked Questions
Who can join the NCT07814105 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Aldosteronism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07814105 currently recruiting?
Yes, NCT07814105 is actively recruiting participants. Contact the research team at edithwkchow@cuhk.edu.hk for enrollment information.
Where is the NCT07814105 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT07814105 clinical trial?
NCT07814105 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 32 participants.