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

NCT06616142 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-01-27

No results posted yet for this study

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

Conditions

  • Primary Aldosteronism

Interventions

DRUG

[18F]CETO tracer

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.

DRUG

Dexamethasone oral

Pre-treatment of dexamethasone prior to 18F CETO PET/CT scan

PROCEDURE

Adrenal vein sampling

Adrenl vein sampling

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Dr. M.N. Kerstens · Department of Internal Medicine - Endocrinology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-06
Primary Completion
2026-10-31
Completion
2027-05-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06616142 on ClinicalTrials.gov