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

NCT05361083 | Completed Early Phase 1

• 1 other identifier: 2018-004831-64
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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?

Conditions

Primary Aldosteronism Due to Aldosterone Producing Adenoma; Primary Aldosteronism Due to Nodular Hyperplasia; Adrenal Cushing Syndrome; Non-Secretory Adrenal Adenoma; Adrenocortical Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  Up to 24 month

• Biodistribution of [18F]CETO

  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.

  Up to 24 month

Study Arms (1)

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.

Drug: F18CETO

Interventions

F18CETO DRUG

Injection of F18CETO or O15water followed by PET/CT

Also known as: Para-chloro-2-[18F]fluoroethyletomidate

First-in-man investigastion of [18F]CETO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with adrenal incidentalomas with an concurrent overproduction of aldosterone or cortisol or no concurrent hormone production, or patients diagnosed with adrenocortical carcinoma

You may not qualify if:

• pregnancy, age below 18, claustrophobia

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator
• British Medical Research Council: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (2)

• 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.

  PMID: 38771379 DERIVED

• Silins 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 DERIVED

MeSH Terms

Conditions

ACTH Syndrome, Ectopic; Adrenocortical Carcinoma

Condition Hierarchy (Ancestors)

Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Per Hellman, Professor

  Uppsala University and Uppsala University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 4, 2022
• Study Start: September 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: February 28, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)