Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism
Recruiting
Phase 2Interventional Study
Primary Aldosteronism
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Diagnostic
Participants needed
30 (estimated)
Sponsor
University of Calgary · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
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…
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.
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