Using a new imaging technique to diagnose types of Primary Aldosteronism
Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism
This study is testing a new imaging method using a special tracer to see if it can better tell the difference between two types of Primary Aldosteronism in people with high blood pressure.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05472493 on ClinicalTrials.gov |
What this trial studies
This phase II study aims to evaluate the accuracy of a novel radiopharmaceutical tracer, para-chloro-2-[18F]fluoroethyl etomidate (CETO), in conjunction with positron emission tomography (PET) and computed tomography (CT), to differentiate between unilateral and bilateral forms of Primary Aldosteronism. The study will recruit 30 participants who meet specific inclusion criteria, including individuals with hypertension and elevated adrenal renin ratios. Participants will receive the CETO tracer followed by imaging to assess the effectiveness of this approach compared to the established adrenal venous sampling (AVS) method.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with hypertension and an elevated adrenal renin ratio, with or without adrenal nodules.
Not a fit: Patients with chronic kidney disease, uncontrolled severe hypertension, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and less invasive method for diagnosing subtypes of Primary Aldosteronism, leading to better-targeted treatments.
How similar studies have performed: While this approach is novel, similar imaging techniques have shown promise in other conditions, but this specific application is currently untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Alexander Leung, MD — University of Calgary
- Study coordinator: Alexander Leung, MD
- Email: aacleung@ucalgary.ca
- Phone: (403) 955-8358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.