Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2023
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
July 24, 2024
July 1, 2024
3.5 years
July 18, 2022
July 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
CETO
EXPERIMENTALThe consented participants will receive the \[18-F\] CETO through the IV and a PET/CT scan afterwards.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Calgary
Calgary, Alberta, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Leung, MD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2022
First Posted
July 25, 2022
Study Start
January 1, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
July 24, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share