CompletedEarly Phase 1

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

Sweden20 participantsStarted 2019-09-01

Plain-language 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?

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT05361083

SponsorUppsala University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-01

View on ClinicalTrials.gov More Primary Aldosteronism Due to Aldosterone Producing Adenoma trials