First-in-human evaluation of [18F]CETO: a novel tracer for adrenocortical tumours.
Isabella Silins, Anders Sundin, Mark Lubberink...
https://pubmed.ncbi.nlm.nih.gov/36074157Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID06616142
Para-chloro-2-[18F]Fluoroethyl-etomidate PET/CT Scan to Subtype Primary Aldosteronism A Pilot Study Comparing [18F]CETO Tracer Uptake with Adrenal Vein Sampling in Adults
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
Researchers are investigating how a new tracer called [18F]CETO is taken up by adrenal tissue in patients with two types of primary aldosteronism (PA), a condition that causes high blood pressure. The study aims to understand the tracer's uptake patterns, compare results with adrenal vein sampling (AVS), and explore how adrenal blood flow affects tracer uptake. This is a pilot study conducted over two years to evaluate the potential of [18F]CETO PET/CT as a less invasive alternative to AVS for subtyping PA. Participants will receive dexamethasone for three days before the scan to improve tracer specificity. They will undergo a PET/CT scan using the [18F]CETO tracer, preceded by a 15O water scan to assess adrenal perfusion. Patients will have already completed routine diagnostic work-up for PA, including hormonal tests, imaging, and AVS. This study is observational and diagnostic in nature, focusing on detailed imaging procedures. During the study, participants will report any side effects from dexamethasone and the scans using questionnaires. Researchers will measure tracer uptake characteristics and compare PET/CT results to AVS findings. Safety monitoring will include watching for mild reversible side effects from dexamethasone. The total duration of participation corresponds with the study timeline of two years, though each participant undergoes a limited number of additional procedures related to the imaging tests.
CONDITIONS
Official Title
Subtyping Primary Aldosteronism With Para-chloro-2-[18F]Fluoroethyl-etomidate
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
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
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
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1
2
3
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
M
Merit Schaafsma, MD-PhD candidate
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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Published Research Related To This Trial
Para-chloro-2-[18F]fluoroethyl-etomidate: A promising new PET radiotracer for adrenocortical imaging.
Isabella Silins, Anders Sundin, Patrik Nordeman...
https://pubmed.ncbi.nlm.nih.gov/33859526