RecruitingPhase 2NCT05472493

Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism


Sponsor

University of Calgary

Enrollment

30 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

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Interventions

BIOLOGICAL[18-F]CETO

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.


Locations(1)

University of Calgary

Calgary, Alberta, Canada

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NCT05472493


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