Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

Sponsor

University of Calgary (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05472493

Collaborator

(none)

Enrollment

Location

Arm

17.9

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Aldosteronism	Biological: [18-F]CETO	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CETO The consented participants will receive the [18-F] CETO through the IV and a PET/CT scan afterwards.	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.

Arm

Intervention/Treatment

Experimental: CETO

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

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.

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Calgary	Calgary	Alberta	Canada

Sponsors and Collaborators

University of Calgary

Investigators

Principal Investigator: Alexander Leung, MD, University of Calgary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Calgary

ClinicalTrials.gov Identifier:

NCT05472493

Other Study ID Numbers:

REB22-0772

First Posted:

Jul 25, 2022

Last Update Posted:

Jul 25, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperaldosteronism

Study Results

No Results Posted as of Jul 25, 2022