Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

Last updated: July 22, 2024
Sponsor: University of Calgary
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

[18-F]CETO

Clinical Study ID

NCT05472493
REB22-0772
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals with hypertension

  • Individuals with an elevated screening adrenal renin ratio (ARR)

  • Individuals with or without spontaneous or diuretic-induced hypokalemia, and/ orplus a discrete adrenal nodule or nodules (1 cm or greater) with concordantlateralization on AVS.

Exclusion

Exclusion Criteria:

  • Individuals with chronic kidney disease (estimated glomerular filtration rate <40mL/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 ofthe liver (e.g., hepatic adenoma or focal nodular hyperplasia)

  • Allergy to intravenous contrast, coagulopathy, use of chronic corticosteroids.

  • Pregnancy, lactation, and pheochromocytoma.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: [18-F]CETO
Phase: 2
Study Start date:
January 01, 2023
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • University of Calgary

    Calgary, Alberta
    Canada

    Active - Recruiting

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