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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 30, 2021

Detailed Description

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.

Interventions

  • Combination Product: 11C-Metomidate PET/CT Scan
    • 11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • Cost-Effectiveness of Diagnostic Test
    • Time Frame: 6 months
    • Cost-Effectiveness of Diagnostic Test to identify unilateral PA

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Changi General Hospital
  • Collaborator
    • National University Health System, Singapore
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.