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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 May 2022
• Main ID: NCT05361083
• Date of registration: 22/04/2022
• Prospective Registration: No
• Primary sponsor: Uppsala University
• Public title: First-in-human Evaluation of [18F]CETO
• Scientific title: Studies of 18F-CETO as a Tracer for Adrenal PET Diagnostics
• Date of first enrolment: September 1, 2019
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT05361083
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

Sweden

Contacts

• Name: Per Hellman, Professor
• Affiliation: Uppsala University and Uppsala University Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Adrenal Cushing Syndrome

Adrenocortical Carcinoma

Non-Secretory Adrenal Adenoma

Primary Aldosteronism Due to Aldosterone Producing Adenoma

Primary Aldosteronism Due to Nodular Hyperplasia

Intervention(s)

Drug: F18CETO

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

Biodistribution of [18F]CETO [Time Frame: Up to 22 month]

Secondary ID(s)

2018-004831-64

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

British Medical Research Council

Uppsala University Hospital