Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism
University of Calgary
30 participants
Jan 1, 2023
INTERVENTIONAL
Conditions
Summary
This study is to evaluate the accuracy of a novel radiopharmaceutical tracer, para-chloro-2-\[18F\]fluoroethyl etomidate (CETO), used with positron emission tomography (PET) and computed tomography (CT), as a way to subtype unilateral vs. bilateral forms of Primary Aldosteronism, compared to AVS as a reference gold standard.
Eligibility
Inclusion Criteria3
- Individuals with hypertension
- Individuals with an elevated screening adrenal renin ratio (ARR)
- Individuals with or without spontaneous or diuretic-induced hypokalemia, and/ or plus a discrete adrenal nodule or nodules (1 cm or greater) with concordant lateralization on AVS.
Exclusion Criteria4
- Individuals with chronic kidney disease (estimated glomerular filtration rate <40 mL/min/1.73m2),
- Individuals with a history of uncontrolled severe hypertension (>180/110 mmHg), severe uncontrolled diabetes, suspected or proven hypercortisolism (e.g., cortisol-secreting adrenal adenoma), or individuals with an anatomical disease of the liver (e.g., hepatic adenoma or focal nodular hyperplasia)
- Allergy to intravenous contrast, coagulopathy, use of chronic corticosteroids.
- Pregnancy, lactation, and pheochromocytoma.
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Interventions
PET/CT will be performed; Non-contrast CT images will be acquired over the adrenals (slice width, \~3 mm). CETO (\~2.5 MBq/kg; up to 365 MBq +/- 20%) will be administered as a single dose intravenously and dynamic PET images will be acquired from \~0-90 minutes.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05472493