Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2021-03-30

Brief Summary

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10% of patients with hypertension potentially have the treatable condition - primary aldosteronism. Primary aldosteronism (PA) is caused by either bilateral adrenal disease (\~40%), managed with lifelong medications; or unilateral disease (\~60%), cured with laparoscopic surgery (adrenalectomy). Unfortunately, many patients with curable hypertension remain undiagnosed and consequently develop cardiac disease and strokes. The difficulty with identifying curable unilateral disease is due to adrenal vein sampling (AVS): an invasive, and technically-difficult procedure, with inconclusive results in 50% of patients. An alternative novel imaging, 11C-metomidate Positron emission tomography-computed tomography (PET-CT), can detect adrenal tumors, and concurrently confirm their over-activity. It is non-invasive, non-operator-dependent, and can identify more patients with curable hypertension.

Investigators hypothesize that 11C-metomidate PET-CT can accurately identify patients with surgically-curable unilateral adrenal disease among hypertensive Asians with primary aldosteronism.

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Detailed Description

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25 patients with confirmed PA who are keen for a surgical cure if unilateral PA is confirmed, will undergo conventional tests, CT, AVS, as well as 11C-metomidate PET/CT.

Results will be reviewed and discussed at a multidisciplinary meeting, and patients with unilateral PA will be offered surgery. Patients will be reviewed 6 months post surgery to assess for cure of PA.

Conditions

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Primary Aldosteronism Primary Aldosteronism Due to Aldosterone Producing Adenoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

11C-metomidate will be manufactured in Clinical Imaging Research Centre in compliance with good manufacturing practice using a General Electric Medical Systems PET trace 860 cyclotron. Non-contrast CT images will be acquired over the adrenal. After an intravenous injection of 11C-metomidate, PET images will be acquired within the first 45 min. Attenuation and decay-corrected images will be converted to standardized uptake value (SUV) maps through division by (injected activity per patient weight). The maximum SUV values over regions of interest will be determined for 10-min static images starting 35 min after the injection.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single Arm

All patients will undergo standard-of-care investigations (CT imaging of adrenals and AVS) and the research test (11C-metomidate PET-CT) with a dose of 150 - 300 Megabecquerel (MBq) (11C-metomidate) to identify functional unilateral adrenal disease.

Group Type EXPERIMENTAL

11C-Metomidate PET/CT Scan

Intervention Type COMBINATION_PRODUCT

11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre

Interventions

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11C-Metomidate PET/CT Scan

11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

• Primary aldosteronism, as defined in Endocrine Society Guidelines 2016, with positive confirmatory test (post-salt loading aldosterone \>140pmol/L); or hypokalemia with undetectable renin levels and aldosterone \>550pmol/L.

Exclusion Criteria

* Inability to provide written informed consent
* \< 21 years or \> 70 years
* Chronic renal failure of Stage 3b or greater severity
* Severe or terminal medical condition(s)
* Contraindications to isotope scanning or CT Scan
* Contraindication to ingestion of corticosteroids

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No