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Search / Trial NCT06616142

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

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Sep 24, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Bilateral Adrenal Hyperplasia Pet/Ct Scan [18 F]Ceto Adrenal Vein Sampling Primary Aldosteronism Aldosteron Producing Adenoma

ClinConnect Summary

This clinical trial is exploring how a special imaging test called \[18F\]CETO PET/CT can help identify different types of primary aldosteronism, a condition that affects the adrenal glands and can lead to high blood pressure. The researchers want to see how well this test can match results from a procedure that takes samples from the adrenal veins. They will also check how blood flow in the adrenal glands might influence the test results. To participate, individuals must be over 18 years old and already diagnosed with primary aldosteronism. They should be able to follow instructions and provide written consent.

If you join the study, you will take a medication called dexamethasone for three days before the imaging test. During the study, you’ll undergo the \[18F\]CETO PET/CT scan and share your experience with the preparations and the scan itself. It's important to note that there are some health conditions and situations that would prevent someone from participating, such as severe diabetes, pregnancy, or certain ongoing infections. Overall, this trial aims to improve our understanding of primary aldosteronism and how to better diagnose its different types.

Gender

ALL

Eligibility criteria

  • 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.

About University Medical Center Groningen

University Medical Center Groningen (UMCG) is a leading academic medical center in the Netherlands, renowned for its commitment to innovative research, high-quality patient care, and extensive education in the medical field. As a prominent sponsor of clinical trials, UMCG leverages its multidisciplinary expertise and state-of-the-art facilities to advance medical knowledge and improve therapeutic outcomes. The center fosters collaboration among researchers, healthcare professionals, and industry partners, aiming to translate scientific discoveries into effective treatments that enhance patient health and well-being. With a focus on ethical standards and regulatory compliance, UMCG is dedicated to conducting clinical trials that contribute to the advancement of medicine and the betterment of society.

Locations

Groningen, , Netherlands

Patients applied

0 patients applied

Trial Officials

Dr. M.N. Kerstens

Principal Investigator

Department of Internal Medicine - Endocrinology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported