Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

Conditions
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Primary Aldosteronism

Intervention / Treatment
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* Biological: [18-F]CETO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CETO<br>The consented participants will receive the [18-F] CETO through the IV and a PET/CT scan afterwards. | Biological: [18-F]CETO<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |