Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

Primary Aldosteronism Clinical Trial

Official title:

Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05472493
• Other study ID #: REB22-0772
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2022
• Source: University of Calgary
• Contact: Alexander Leung, MD
• Phone: (403) 955-8358
• Email: aacleung[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Intervention

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

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.