Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

NCT ID: NCT05472493

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-06-30

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.

Conditions

Primary Aldosteronism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CETO

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

Group Type: EXPERIMENTAL

[18-F]CETO

Intervention Type: BIOLOGICAL

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.

Interventions

[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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Leung, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Alexander Leung, MD

Role: CONTACT

aacleung@ucalgary.ca

(403) 955-8358

Facility Contacts

Alexander Leung, MD

Role: primary

aacleung@ucalgary.ca

(403) 955-8358

Other Identifiers

REB22-0772

Identifier Type: -

Identifier Source: org_study_id