SFEBES2021 Oral Poster Presentations Adrenal and Cardiovascular (4 abstracts)
A phase 1 clinical trial evaluating the safety and efficacy of up to two administrations of the adrenal PET tracer [18F]CETO in healthy volunteers and patients with primary aldosteronism
Russell Senanayake 1,2 , Daniel Gillett 2 , Waiel Bashari 1,2 , James MacFarlane 1,2 , Lihua Hu 2 , August Palma 2 , Luigi Aloj 3 , Iosif Mendichovszky 3 , Stefan Hader 3 , Istvan Boros 3 , Morris Brown 4,5 , Heok Cheow 3 , Franklin Aigbirhio 1,3 & Mark Gurnell 1,2
1University of Cambridge, Cambridge, United Kingdom; 2Wellcome-MRC Institute of Metabolic Science, Addenbrooke’s Hospital, Cambridge, United Kingdom; 3Addenbrooke’s Hospital, Cambridge, United Kingdom; 4William Harvey Research Institute, Queen Mary University of London, London, United Kingdom; 5NIHR Barts Hospital Biomedical Research Centre, London, United Kingdom
Background: Primary aldosteronism (PA) is an important, potentially curable, cause of hypertension. Distinguishing unilateral and bilateral causes is a critical step in determining who should be considered for adrenalectomy. Adrenal vein sampling (AVS) remains the gold standard for lateralisation. However, AVS is technically challenging with limited availability. To address this, we have introduced molecular imaging using PET/CT with the radiotracer [11C]Metomidate (MTO-PET) as an alternative for lateralisation/localisation of aldosterone-producing adenomas and nodules. However, its utility is limited by the short tracer half-life, restricting its availability to centres with an on-site cyclotron. Here, we report initial findings with a related radiotracer with a longer half-life, [18F]CETO.
Methods: We conducted a phase 1, single-centre, open-label, micro-dosing study. The primary objective was to evaluate the safety of up to two administrations of [18F]CETO in six patients with PA (three unilateral, three bilateral) and five healthy volunteers. Safety assessments included a 250mcg Synacthen test at screening and morning after initial [18F]CETO administration. The secondary objectives were to assess normal adrenal uptake, and to evaluate findings in unilateral versus bilateral PA in patients undergoing two scans – with and without dexamethasone pre-treatment.
Results: No serious adverse events/reactions occurred; a single adverse event (minor flushing) was observed following Synacthen injection in one patient unrelated to tracer administration. All subjects had preserved adrenal function. [18F]CETO-PET demonstrated selective adrenal uptake in healthy volunteers and patients with PA. Following dexamethasone, [18F]CETO was able to distinguish unilateral and bilateral disease.
Conclusion: In this first-in-human study, [18F]CETO was shown to be safe and exhibited selective adrenal uptake. Preliminary findings in a small number of patients with PA suggest it can distinguish unilateral and bilateral causes of PA. If these findings are confirmed in larger studies, [18F]CETO may provide a more widely available alternative to AVS.
Volume 77
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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