Overview
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.
Description
This is a phase II study (with targeted recruitment of 30 participants) designed 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. Subjects consenting to study participation will receive the \[18-F\] CETO followed by the PET/CT scan.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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.
