Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate
- Conditions
- Primary Aldosteronism Due to Aldosterone Producing AdenomaPrimary Aldosteronism
- Interventions
- Combination Product: 11C-Metomidate PET/CT Scan
- Registration Number
- NCT03990701
- Lead Sponsor
- Changi General Hospital
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
• 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm 11C-Metomidate PET/CT Scan 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.
- Primary Outcome Measures
Name Time Method Cure of Primary Aldosteronism Post-Adrenalectomy 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 Outcome Measures
Name Time Method Clinical Diagnosis of Unilateral Primary Aldosteronism 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 6 months Cost-Effectiveness of Diagnostic Test to identify unilateral PA
Trial Locations
- Locations (1)
Changi General Hospital
🇸🇬Singapore, Singapore