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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllUniversity Medical Center Groningen
NCT06616142 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * above 18 years * Biochemically established diagnosis of PA\* * Completion of standard diagnostic work-up of PA\* * Able to follow and understand instructions to participate in the study * Able to give written informed consent. Exclusion Criteria: * diabetes mellitus (i.e., HbA1c above 42 mmol/mol, and/or fasting plasma glucose \> 7.0 mol/l or non-fasting plasma glucose above 11.1 mmol/L ) * serious comorbidities precluding surgery * severe claustrophobia * pregnancy/breastfeeding or unable/unwilling to take adequate contraceptives (female only) * concurrent active infections (e.g., viral, fungal or parasite infections)\*\* * problematic venous access * unable/unwilling to take dexamethasone prior to \[18F\]CETO scanning * inability to temporary stop medication affecting aldosterone secretion * use of ketoconazole, metyrapone or cytostatic drugs during previous 6 months\*\*\* * long-term use of prednisolone and/or dexamethasone.
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What it tests

  • [18F]CETO tracer
  • Dexamethasone oral
  • Adrenal vein sampling
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Where

1 site
University Medical Center Groningen
Groningen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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