Primary Aldosteronism
Conditions
Brief 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.
Detailed 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.
Interventions
BIOLOGICAL[18-F]CETO
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.
Sponsors
University of Calgary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is diagnostic test accuracy (expressed as sensitivity, specificity, positive predictive value, and negative predictive value) for CETO PET/CT using adrenal vein sampling as a reference standard. | It will be measured using adrenal vein sampling approximately the same time as the CETO PET/CT. |
Countries
Canada
Contacts
Primary ContactAlexander Leung, MD
Outcome results
None listed