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New treatment option for Primary Aldosteronism
Official title Subtyping Primary Aldosteronism With Para-chloro-2-[18F]Fluoroethyl-etomidate
ClinicalTrials.gov ID: NCT06616142
What this study is testing
What is [18F]CETO tracer?
[18F]CETO tracer is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for primary aldosteronism.
Also referred to as Para-chloro-2-[18F]fluoroethyl-etomidate ([18F]CETO).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Provincie Groningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Provincie Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.