Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

University of Calgary

Status and phase: Enrolling; Phase 2

Conditions: Primary Aldosteronism

Treatments: Biological: [18-F]CETO

Study type: Interventional

Funder types: Other

Identifiers

NCT05472493

REB22-0772

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

CETO

Experimental group

Description:

The consented participants will receive the \[18-F\] CETO through the IV and a PET/CT scan afterwards.

Treatment:

Biological: [18-F]CETO