First-in-human Evaluation of [18F]CETO
Study Details
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?
Condition or Disease | Intervention/Treatment | Phase |
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Early Phase 1 |
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:
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A physical examination according to Modified Early Warning Score (MEWS)
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12-lead electrocardiogram (ECG)
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Any concomitant medications was recorded
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Medical history - occurrence of any new symptoms and events since the screening visit
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Hematology (International Normalized Ratio (INR) in patients with antiocoagulant treatment).
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Pregnancy test in women.
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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:
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Blood withdrawn for additional post-scan chemical analysis.
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Assessment of injection site monitored by visual inspection (rash and phlebitis).
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 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. |
Drug: F18CETO
Injection of F18CETO or O15water followed by PET/CT
Other Names:
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Outcome Measures
Primary Outcome Measures
- Evaluate safety of up to two administrations of [18F]CETO in up to 15 patients in comparison with 5 healthy controls. [Up to 1 day after the [18F]CETO PET/CT for each patient]
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)
Secondary Outcome Measures
- Evaluate [18F]CETO as a PET- biomarker for the adrenals and to diagnose and visualize primary aldosteronism, cortisol producing adrenocortical adenoma and non-functioning adrenocortical adenoma in up to 15 patients [Up to 24 month]
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.
- Biodistribution of [18F]CETO [Up to 22 month]
Measurement of SUV for organs was determined.
- Compare uptake of [18F]CETO in normal adrenal glands in patients comparing healthy controls and determine the test - retest variability of [18F]CETO. [Up to 24 month]
Difference in SUV in the adrenal glands between two investigations in the samt participant was determined.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients diagnosed with adrenal incidentalomas with an concurrent overproduction of aldosterone or cortisol or no concurrent hormone production, or patients diagnosed with adrenocortical carcinoma
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For healthy volunteers inclusion criteria included no known diseases, no ongoing medication and no known adrenal anomalies.
Exclusion Criteria for patients and healthy volunteers:
- pregnancy, age below 18, claustrophobia
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Uppsala University Hospital | Uppsala | Sweden | 75185 |
Sponsors and Collaborators
- Uppsala University
- Uppsala University Hospital
- British Medical Research Council
Investigators
- Study Director: Per Hellman, Professor, Uppsala University and Uppsala University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-004831-64