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?

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

Primary Aldosteronism Due to Aldosterone Producing Adenoma

Primary Aldosteronism Due to Nodular Hyperplasia

Adrenal Cushing Syndrome

Non-Secretory Adrenal Adenoma

Adrenocortical Carcinoma

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        -  Blood withdrawn for additional post-scan chemical analysis.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.

F18CETO

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.

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.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status