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NCT Number: NCT03990701

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

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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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Cardiovascular Diseases Endocrine System Diseases Hyperaldosteronism Hypertension Primary Aldosteronism Due to Aldosterone Producing Adenoma Vascular Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Changi General Hospital

Singapore, 529889

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

11C-Metomidate PET/CT Scan

Combination Product

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

Primary outcomes

  1. Cure of Primary Aldosteronism Post-Adrenalectomy

    Time frame: 6 months

    Percentage of patients accurately identified with unilateral PA (determined by post-surgery biochemical cure) using 11C-metomidate PET/CT compared to percentage of patients accurately identified with unilateral PA (determined by post-surgery biochemical cure) using AVS

Secondary outcomes

  1. Clinical Diagnosis of Unilateral Primary Aldosteronism

    Time frame: 6 months

    Percentage of patients accurately identified with unilateral PA (determined by clinical diagnosis made by multidisciplinary team) using 11C-metomidate PET/CT compared to percentage of patients accurately identified with unilateral PA (determined by clinical diagnosis made by multidisciplinary team) using AVS

  2. Cost-Effectiveness of Diagnostic Test

    Time frame: 6 months

    Cost-Effectiveness of Diagnostic Test to identify unilateral PA

Other outcomes

  1. Diagnostic criteria using 11C-Metomidate PET/CT

    Time frame: 6 months

    To assess the cut-off level of SUVmax which offers the best sensitivity and specificity for lateralisation in 11C-metomidate PET-CT

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Collaborators

  • Clinical Imaging Research Centre
  • Khoo Teck Puat Hospital
  • National University Health System, Singapore
  • Ng Teng Fong General Hospital
  • Singapore General Hospital
  • Tan Tock Seng Hospital

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2019
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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