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Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

NCT05472493•University of Calgary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (1)

University of Calgary

Calgary, Alberta, Canada

Key Dates

Start Date

January 1, 2023

Primary Completion Date

June 30, 2026

Completion Date

June 30, 2026

Last Updated

July 24, 2024

Enrollment

ESTIMATED participants

Conditions

Primary Aldosteronism

Interventions

[18-F]CETO

BIOLOGICAL

Contacts

Alexander Leung, MD

CONTACT

(403) 955-8358 aacleung@ucalgary.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

Inclusion Criteria

Exclusion Criteria

Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA

68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT)

Prognosis of Primary Aldosteronism: A Prospective Cohort Study

Steroids-Based Screening for Primary Aldosteronism

Sequential Combined Versus Single-Strategy Adrenal Venous Sampling for Primary Aldosteronism(SCOPE)

PETAL Trial: Impact of Gallium-68 Pentixafor PET-CT on Surgical Outcomes in Primary Aldosteronism