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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.

Injection of F18CETO or O15water followed by PET/CT

F18CETO

Per Hellman, Professor

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?

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.

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

Studies of 18F-CETO as a Tracer for Adrenal PET Diagnostics

Number of patients with treatment-related adverse events as assessed by clinical Adverse Events and Common ToxicityNCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE)

Arterial blood was collected to determined the fraction of intact \[18F\]CETO in plasma. PET- modelling based on dynamic PET-data and metabolite analysis was performed for scientific purposes. Measurement of Standard Uptake Value (SUV) was determined for the adrenal glands.

Measurement of SUV for organs was determined.

Difference in SUV in the adrenal glands between two investigations in the samt participant was determined.

Uppsala University Hospital

British Medical Research Council

Uppsala University

Pheochromocytoma

Death

Death, Sudden

Paraganglioma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Paragangliomas 1

Neuroendocrine Tumor

Neuroepithelioma

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Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

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Adrenergic Agonists

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Mydriatics

Sympathomimetics

Unexpected witnessed death occurring within an hour of the onset of symptoms in a person with or without previously known cardiac disease without an extra-cardiac cause, or unexpected unwitnessed death without extra-cardiac cause occurring in the previous 24 hours

Death because of an exogenic reason for sudden death such as trauma or suicide as a control group i.e. non-disease-induced sudden death

Immunoshistochemical diagnosis of primary aldosteronism

Adrenal aldosterone synthase (CYP11B2) staining

Immunoshistochemical diagnosis of adrenal hypercortisolism

Adrenal cortisol synthase (CYP11B1) staining

Diagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism

Histopathological analysis

Niina Matikainen, MD, PhD, Assoc Prof

Sudden Cardiac Death is a leading cause of mortality and remains a major public health burden worldwide. Cardiac arrest due to coronary heart disease explains a large proportion of the cases, but if autopsy is not performed the exact underlying cause remains obscure in many adults who face sudden death outside heath care organizations. The investigators aim to find proof that primary aldosteronism is a risk factor for sudden death and to characterize the prevalence of adrenal pathology in sudden death of undetermined cause in a case-control study. In addition, the study aims to characterize the prevalence of other adrenal pathology i.e. silent adenomas, cortisol-producing adenomas and pheochromocytomas in sudden death. The investigators also seek evidence that other endocrine hormone overproduction-causing diseases are more prevalent in persons with sudden death compared with those experiencing traumatic or suicidal death sudden death.

Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death

Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death Without Definitive Causative Diagnosis (PEA-SuddenDeath)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
First-in-human Evaluation of [18F]CETO	NCT05361083	Primary Aldoste... Primary Aldoste... Adrenal Cushing... Non-Secretory A... Adrenocortical ...	F18CETO	18 Years -	Uppsala University
Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death	NCT05446779	Primary Aldoste... Adrenal Cushing... Pheochromocytom... Endocrine Neopl...	Adrenal aldoste... Adrenal cortiso... Histopathologic...	35 Years - 70 Years	Helsinki University Central Hospital

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