Spots Global Cancer Trial Database for First-in-human Evaluation of [18F]CETO

Study Description

Brief Summary: 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?

Detailed Description: 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observation at least 3 hours after administration of \[18F\]CETO and the following assessments were performed: * Blood withdrawn for additional post-scan chemical analysis.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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Contact Details

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