Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma
Conditions
Keywords
11-C Metomidate PET/CT, Hypertension, Adrenalectomy, Adrenal Vein Sampling, Subtyping
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.
Interventions
COMBINATION_PRODUCT11C-Metomidate PET/CT Scan
11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre
Sponsors
National University Health System, Singapore
Clinical Imaging Research Centre
Singapore General Hospital
Tan Tock Seng Hospital
Khoo Teck Puat Hospital
Ng Teng Fong General Hospital
Changi General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic criteria using 11C-Metomidate PET/CT | 6 months | To assess the cut-off level of SUVmax which offers the best sensitivity and specificity for lateralisation in 11C-metomidate PET-CT |
Countries
Singapore
Outcome results
None listed