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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorChinese University of Hong Kong

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • [11C] Metomidate PETCT

    Procedure/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 Sampling

    Procedure/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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: MTO-PETExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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