First-in-human Evaluation of [18F]CETO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Purpose of this clinical phase 1 trial was to determine if para-chloro-2-\[18F\]fluoroethyletomidate positron emission computed tomography (\[18F\]CETO-positron emission computed tomography(PET)/computed tomography(CT)) can be used in diagnostics of adrenal tumors and if the biochemical/pharmacological states conditions in humans with various illnesses, compared to healthy humans, such as the radio tracer is suitable?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CETO First in Human Trial

NCT04529018

Primary Aldosteronism

UNKNOWN NA

First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging

NCT05335811

Endocrine Neoplasia

RECRUITING PHASE1

Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism

NCT05472493

Primary Aldosteronism

RECRUITING PHASE2

Validation of 3-[11C]-OHB

NCT05232812

Diabetes Mellitus, Type 2 Heart Failure Healthy

COMPLETED NA

Molecular Pituitary Imaging Using 18F-FET PET

NCT06584123

Pituitary Adenoma

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

After receiving oral and written information about the study and its potential risks, all participants provided written informed consent. All participants underwent a screening visit 1-28 days before their \[18F\]CETO PET/CT. At the screening visit their medical history was obtained, including besides information of previous disease(s) and medication, also a clinical examination, WHO performance status, height, weight, pulse rate and blood pressure, blood chemistry and haematology.

Right before the PET/CT investigation a baseline assessment was performed including:

* A physical examination according to Modified Early Warning Score (MEWS)
* 12-lead electrocardiogram (ECG)
* Any concomitant medications was recorded
* Medical history - occurrence of any new symptoms and events since the screening visit
* Hematology (International Normalized Ratio (INR) in patients with antiocoagulant treatment).
* Pregnancy test in women.
* Assessment of injection site monitored by visual inspection (rash and phlebitis)

Participants received on average 0,76 mikrograms (range 0,1-1.37 mikrograms) of administered mass of CETO in conjunction to the PET/CT investigation.

Potential adverse events were monitored closely during, and after the administration of \[18F\]CETO, with access to emergency medicine resources.

Each participant remained for observation at least 3 hours after administration of \[18F\]CETO and the following assessments were performed:

* Blood withdrawn for additional post-scan chemical analysis.
* Assessment of injection site monitored by visual inspection (rash and phlebitis).
* MEWS

The ten first participants were evaluated for serious adverse events/adverse events (SAE/AEs) the day after (approximately 24 hours after) performing the \[18F\]CETO PET due to the short half-life of the radionuclide used, fluorine- 18 (T1/2= 109.5 min). Safety reporting was assessed by use of clinical Adverse Events and Common Toxicity Criteria (CTC), laboratory and non-laboratory toxicities.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Aldosteronism Due to Aldosterone Producing Adenoma Primary Aldosteronism Due to Nodular Hyperplasia Adrenal Cushing Syndrome Non-Secretory Adrenal Adenoma Adrenocortical Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

First-in-man investigastion of [18F]CETO

15 patients were investigated with PET/CT after injection of 2,5 MBq/kg \[18F\]CETO. 5 healthy volunteers were investigated twice (Test-retest), with approximately 2 weeks in-between each PET/CT investigation, after injection of 1,3 MBq/kg \[18F\]CETO. Arterial blood samples were taken as well as urinary sampels.

3 out of 5 healthy volunteers were also investigated twice with PET/CT after injection of 13,2 MBq/kg \[15O\]water, performed before the \[18F\]CETO PET/CT.

Group Type EXPERIMENTAL

F18CETO

Intervention Type DRUG

Injection of F18CETO or O15water followed by PET/CT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

F18CETO

Injection of F18CETO or O15water followed by PET/CT

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Para-chloro-2-[18F]fluoroethyletomidate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients diagnosed with adrenal incidentalomas with an concurrent overproduction of aldosterone or cortisol or no concurrent hormone production, or patients diagnosed with adrenocortical carcinoma