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for observation at least 3 hours after administration of [18F]CETO and the following assessments were performed:~Blood withdrawn for additional post-scan chemical analysis.~Assessment of injection site monitored by visual inspection (rash and phlebitis).~MEWS~The ten first participants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.
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?