Clinical trial · Interventional
First-in-human Evaluation of [18F]CETO
Studies of 18F-CETO as a Tracer for Adrenal PET Diagnostics
NCT05361083CI-TRIAL-00058252completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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?
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenal Cushing Syndrome | — | UNRESOLVED | — |
| Adrenocortical Carcinoma | Adrenal Cortical Carcinoma | ALIAS | 0.90 |
| Non-Secretory Adrenal Adenoma | — | UNRESOLVED | — |
| Primary Aldosteronism Due to Aldosterone Producing Adenoma | — | UNRESOLVED | — |
| Primary Aldosteronism Due to Nodular Hyperplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F18CETO | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- First-in-man investigastion of [18F]CETO
- description
- 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.
- interventionNames
- Drug: F18CETO
Primary outcomes (1)
- measure
- Evaluate safety of up to two administrations of [18F]CETO in up to 15 patients in comparison with 5 healthy controls.
- timeFrame
- Up to 1 day after the [18F]CETO PET/CT for each patient
- description
- 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 outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria for patients and healthy volunteers: * pregnancy, age below 18, claustrophobia
References
Publications (2)
- DERIVEDSilins 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. PMID 38771379
- DERIVEDSilins 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. PMID 36074157