Subtyping Primary Aldosteronism With Para-chloro-2-[18F]Fluoroethyl-etomidate (NCT06616142) | Clinical Trial Compass
RecruitingPhase 1/2
Subtyping Primary Aldosteronism With Para-chloro-2-[18F]Fluoroethyl-etomidate
Netherlands12 participantsStarted 2024-11-06
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.