Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06616142

Subtyping Primary Aldosteronism With Para-chloro-2-[18F]Fluoroethyl-etomidate

Led by University Medical Center Groningen · Updated on 2025-01-27

12

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to investigate the uptake characteristics of \[18F\]CETO in adrenal tissue in patients with two different subtypes of primary aldosteronism. The main questions it aims to answer are: * What are the uptake characteristics of \[18F\]CETO in adrenal tissue in patients with primary aldosteronism? * What is the concordance between the adrenal vein sampling and the \[18F\]CETO PET/CT scan results? * What is the effect of adrenal perfusion on \[18F\]CETO uptake in the adrenal glands? Researchers will compare the results of the adrenal vein sampling to a \[18F\]CETO PET/CT scan to see if the PET/CT can accurately identify the subtypes of primary aldosteronism. Participants will: * Take dexamethasone three days prior to the scan * Undergo a \[18F\]CETO PET/CT * Report burden of pre-treatment and PET/CT scan

CONDITIONS

Official Title

Subtyping Primary Aldosteronism With Para-chloro-2-[18F]Fluoroethyl-etomidate

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged above 18 years
  • Biochemically confirmed diagnosis of primary aldosteronism
  • Completion of standard diagnostic work-up for primary aldosteronism
  • Ability to follow and understand study instructions
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Diabetes mellitus with HbA1c above 42 mmol/mol or elevated fasting/non-fasting plasma glucose
  • Serious health problems preventing surgery
  • Severe claustrophobia
  • Pregnancy, breastfeeding, or inability/unwillingness to use effective contraception (female only)
  • Active infections such as viral, fungal, or parasitic infections
  • Difficult venous access
  • Unwillingness or inability to take dexamethasone before the PET/CT scan
  • Inability to temporarily stop medications that affect aldosterone secretion
  • Use of ketoconazole, metyrapone, or cytostatic drugs in the past 6 months
  • Long-term use of prednisolone or dexamethasone

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands, 9713 GZ

Actively Recruiting

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Research Team

D

dr. M.N. Kerstens

CONTACT

M

Merit Schaafsma, MD-PhD candidate

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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