Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

Phase 2

Recruiting

• Conditions: Primary Aldosteronism
• Interventions: Biological: [18-F]CETO

• Registration Number: NCT05472493
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-22
• Study First Posted: 2022-07-25
• Study Start: 2023-01-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada