Primary Aldosteronism Due to Aldosterone Producing AdenomaEarly Phase 1NCT05361083
First-in-human Evaluation of [18F]CETO
A Early Phase 1 study testing F18CETO in people with Primary Aldosteronism Due to Aldosterone Producing Adenoma and Primary Aldosteronism Due to Nodular Hyperplasia, run by Uppsala University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Nodular Hyperplasia, Adrenal Cushing Syndrome
- What is being tested?
- F18CETO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2019to 28 Feb 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with adrenal incidentalomas with an concurrent overproduction of aldosterone or cortisol or no concurrent hormone production, or patients diagnosed with adrenocortical carcinoma
- For healthy volunteers inclusion criteria included no known diseases, no ongoing medication and no known adrenal anomalies.
Who cannot join
- pregnancy, age below 18, claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studies of 18F-CETO as a Tracer for Adrenal PET Diagnostics
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?
Read the 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.
- Conditions
- Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Nodular Hyperplasia, Adrenal Cushing Syndrome, Non-Secretory Adrenal Adenoma, Adrenocortical Carcinoma
- Being tested
- F18CETO
- Medical subject headings
- ACTH Syndrome, Ectopic, Adrenocortical Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F18CETODrug
Also called Para-chloro-2-[18F]fluoroethyletomidate
Injection of F18CETO or O15water followed by PET/CT
| Study group | Role | What they receive |
|---|---|---|
| First-in-man investigastion of [18F]CETO | Experimental | 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. Receives: Drug: F18CETO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety of up to two administrations of [18F]CETO in up to 15 patients in comparison with 5 healthy controls.
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)
Measured: Up to 1 day after the [18F]CETO PET/CT for each patient
Secondary outcomes (3)
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
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.
Measured: Up to 24 month
Biodistribution of [18F]CETO
Measurement of SUV for organs was determined.
Measured: Up to 22 month
Compare uptake of [18F]CETO in normal adrenal glands in patients comparing healthy controls and determine the test - retest variability of [18F]CETO.
Difference in SUV in the adrenal glands between two investigations in the samt participant was determined.
Measured: Up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Sep 2019
- Primary completion1 Apr 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Aldosteronism Due to Aldosterone Producing AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, British Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Per Hellman, Professor, Study director, Uppsala University and Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361083
- Sponsor's protocol ID
- 2018-004831-64
- Other IDs
- 2018
- Status last verified
- Apr 2022
- First submitted
- 22 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silins I, Moreno A, Wall A, Aigbirhio F, Gurnell M, Brown M, Roslin S, Antoni G, Hellman P, Sundin A, Lubberink M. Radiation dosimetry of para-chloro-2-[18F]fluoroethyl-etomidate: a PET tracer for adrenocortical imaging. EJNMMI Res. 2024 May 21;14(1):48. doi: 10.1186/s13550-024-01109-2.
PubMed 38771379Silins I, Sundin A, Lubberink M, O'Sullivan L, Gurnell M, Aigbirhio F, Brown M, Wall A, Akerstrom T, Roslin S, Hellman P, Antoni G. First-in-human evaluation of [18F]CETO: a novel tracer for adrenocortical tumours. Eur J Nucl Med Mol Imaging. 2023 Jan;50(2):398-409. doi: 10.1007/s00259-022-05957-9. Epub 2022 Sep 8.
PubMed 36074157
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of 18F-CETO as a Tracer for Adrenal PET Diagnostics
- ClinicalTrials.gov ID
- NCT05361083
- Acronym / sponsor ID
- 2018-004831-64
- Conditions
- Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Nodular Hyperplasia, Adrenal Cushing Syndrome, Non-Secretory Adrenal Adenoma, Adrenocortical Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, British Medical Research Council
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-in-man investigastion of [18F]CETO | Experimental | Drug: F18CETO15 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with adrenal incidentalomas with an concurrent overproduction of aldosterone or cortisol or no concurrent hormone production, or patients diagnosed with adrenocortical carcinoma
- For healthy volunteers inclusion criteria included no known diseases, no ongoing medication and no known adrenal anomalies.
Key exclusion criteria (1 listed)
- pregnancy, age below 18, claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F18CETOAlso: Para-chloro-2-[18F]fluoroethyletomidateInjection of F18CETO or O15water followed by PET/CT | Drug | First-in-man investigastion of [18F]CETO |
Primary outcome
Evaluate safety of up to two administrations of [18F]CETO in up to 15 patients in comparison with 5 healthy controls.
Time frame: 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)
3 secondary outcomes
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
Time frame: Up to 24 month
Biodistribution of [18F]CETO
Time frame: Up to 22 month
Compare uptake of [18F]CETO in normal adrenal glands in patients comparing healthy controls and determine the test - retest variability of [18F]CETO.
Time frame: Up to 24 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 38771379Silins I, Moreno A, Wall A, Aigbirhio F, Gurnell M, Brown M, Roslin S, Antoni G, Hellman P, Sundin A, Lubberink M. Radiation dosimetry of para-chloro-2-[18F]fluoroethyl-etomidate: a PET tracer for adrenocortical imaging. EJNMMI Res. 2024 May 21;14(1):48. doi: 10.1186/s13550-024-01109-2.
- Derived from this study: PubMed 36074157Silins I, Sundin A, Lubberink M, O'Sullivan L, Gurnell M, Aigbirhio F, Brown M, Wall A, Akerstrom T, Roslin S, Hellman P, Antoni G. First-in-human evaluation of [18F]CETO: a novel tracer for adrenocortical tumours. Eur J Nucl Med Mol Imaging. 2023 Jan;50(2):398-409. doi: 10.1007/s00259-022-05957-9. Epub 2022 Sep 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Hellman, Professor study director
Uppsala University and Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing F18CETO in people with Primary Aldosteronism Due to Aldosterone Producing Adenoma and Primary Aldosteronism Due to Nodular Hyperplasia, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety of up to two administrations of [18F]CETO in up to 15 patients in comparison with 5 healthy controls. (time frame: Up to 1 day after the [18F]CETO PET/CT for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05361083, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022; AzTrials last refreshed its copy on 1 Nov 2026.