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

NCT06616142 | Recruiting Phase 1

• 2 other identifiers: SPACE 2024/1762023-508254-26-00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bilateral adrenal hyperplasia; PET/CT scan; [18F]CETO; Adrenal vein sampling; Primary aldosteronism; Aldosteron producing Adenoma

Outcome Measures

Primary Outcomes (1)

• Uptake characteristics [18F]CETO

  Visual description of uptake characteristics of \[18F\]CETO uptake in adrenal tissue in patients with APA or BAH.

  2 years

Secondary Outcomes (1)

• Concordance adrenal vein sampling and [18F]CETO PET/CT scan

  2 years

Study Arms (2)

Aldosterone producing adenoma

ACTIVE COMPARATOR

Patients diagnosed with an aldosterone producing adenoma

Drug: [18F]CETO tracer; Drug: Dexamethasone oral; Procedure: Adrenal vein sampling

Bilateral adrenal hyperplasia

ACTIVE COMPARATOR

Patients diagnosed with bilateral adrenal hyperplasia

Drug: [18F]CETO tracer; Drug: Dexamethasone oral; Procedure: Adrenal vein sampling

Interventions

[18F]CETO tracer DRUG

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.

Also known as: Para-chloro-2-[18F]fluoroethyl-etomidate ([18F]CETO)

Aldosterone producing adenoma; Bilateral adrenal hyperplasia

Dexamethasone oral DRUG

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

Aldosterone producing adenoma; Bilateral adrenal hyperplasia

Adrenal vein sampling PROCEDURE

Adrenl vein sampling

Also known as: AVS

Aldosterone producing adenoma; Bilateral adrenal hyperplasia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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
• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

RECRUITING

Related Publications (2)

• Silins I, Sundin A, Lubberink M, O'Sullivan L, Gurnell M, Aigbirhio F, Brown M, Wall A, Akerstrom T, Roslin S, Hellman P, Antoni G. First-in-human evaluation of [18F]CETO: a novel tracer for adrenocortical tumours. Eur J Nucl Med Mol Imaging. 2023 Jan;50(2):398-409. doi: 10.1007/s00259-022-05957-9. Epub 2022 Sep 8.

  PMID: 36074157 BACKGROUND

• Silins I, Sundin A, Nordeman P, Jahan M, Estrada S, Monazzam A, Lubberink M, Aigbirhio F, Hellman P, Antoni G. Para-chloro-2-[18F]fluoroethyl-etomidate: A promising new PET radiotracer for adrenocortical imaging. Int J Med Sci. 2021 Mar 21;18(10):2187-2196. doi: 10.7150/ijms.51206. eCollection 2021.

  PMID: 33859526 BACKGROUND

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Dr. M.N. Kerstens

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

dr. M.N. Kerstens

CONTACT

+31 0503613518; m.n.kerstens@umcg.nl

Merit Schaafsma, MD-PhD candidate

CONTACT

+31503610972; m.schaafsma@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All study participants will receive an adrenal vein sampling and a \[18F\]CETO PET/CT scan.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 27, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After end of study.
• Access Criteria: Described in the data management plan

Locations

NL (1)