Subtyping Primary Aldosteronism With Para-chloro-2-[18F]Fluoroethyl-etomidate
Para-chloro-2-[18F]Fluoroethyl-etomidate ([18F]CETO) as a New PET-tracer for Subtyping in Patients With Primary Aldosteronism - a Pilot Study
University Medical Center Groningen
12 participants
Nov 6, 2024
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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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Interventions
PET/CT with para-chloro-2-\[18F\]fluoroethyl-etomidate (\[18F\]CETO) has a high specificity for the steroidogenic enzymes CYP11B1 and CYP11B2, present in the adrenal cortex, and has more favourable tracer characteristics compared to \[11C\]metomidate. Results obtained with this novel tracer seem promising, but its potential value in the subtyping of PA needs to be further established.
Pre-treatment of dexamethasone prior to 18F CETO PET/CT scan
Adrenl vein sampling
Locations(1)
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NCT06616142