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Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

Primary Purpose

Primary Aldosteronism

Status
Not yet recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
[18-F]CETO
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Aldosteronism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CETO

Arm Description

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

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
July 18, 2022
Last Updated
July 22, 2022
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT05472493
Brief Title
Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism
Official Title
Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CETO
Arm Type
Experimental
Arm Description
The consented participants will receive the [18-F] CETO through the IV and a PET/CT scan afterwards.
Intervention Type
Biological
Intervention Name(s)
[18-F]CETO
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
It will be measured using adrenal vein sampling approximately the same time as the CETO PET/CT.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Leung, MD
Phone
(403) 955-8358
Email
aacleung@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Leung, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Leung, MD
Phone
(403) 955-8358
Email
aacleung@ucalgary.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

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