Recruiting
Phase 2

CETO

Sponsor:

University of Calgary

Code:

NCT05472493

Conditions

Primary Aldosteronism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18-F]CETO

Study Details

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.

Conditions

Primary Aldosteronism

Study ID

NCT05472493

Start date

Jan 1, 2023

Status verified date

Jul, 2024

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: CETO

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

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Alexander Leung, MD

(403) 955-8358aacleung@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada

Contacts

Alexander Leung, MD

(403) 955-8358aacleung@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Jul 24, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2024-07-24.