CETO First in Human Trial

Summary

The study is a Phase 1, single-centre, open label, micro-dosing study. The aim is to investigate an innovative new tracer, \[18F\]CETO, as a potential alternative to adrenal vein sampling for the lateralisation of primary aldosteronism (PA).

Timeline

Start

2020-08-03

Primary completion

2020-11-30

Completion

2020-11-30

Publications

• Background Burton TJ, Mackenzie IS, Balan K, Koo B, Bird N, Soloviev DV, Azizan EA, Aigbirhio F, Gurnell M, Brown MJ. Evaluation of the sensitivity and specificity of (11)C-metomidate positron emission tomography (PET)-CT for lateralizing aldosterone secretion by Conn's adenomas. J Clin Endocrinol Metab. 2012 Jan;97(1):100-9. doi: 10.1210/jc.2011-1537. Epub 2011 Nov 23.
• Background Hahner S, Stuermer A, Kreissl M, Reiners C, Fassnacht M, Haenscheid H, Beuschlein F, Zink M, Lang K, Allolio B, Schirbel A. [123 I]Iodometomidate for molecular imaging of adrenocortical cytochrome P450 family 11B enzymes. J Clin Endocrinol Metab. 2008 Jun;93(6):2358-65. doi: 10.1210/jc.2008-0050. Epub 2008 Apr 8.
• Background Bergstrom M, Juhlin C, Bonasera TA, Sundin A, Rastad J, Akerstrom G, Langstrom B. PET imaging of adrenal cortical tumors with the 11beta-hydroxylase tracer 11C-metomidate. J Nucl Med. 2000 Feb;41(2):275-82.
• Gillett D, Senanayake R, MacFarlane J, Bashari W, Palma A, Hu L, Harper I, Mendichovszky IA, Antoni G, Hellman P, Sundin A, Hird M, Boros I, Brown MJ, Cheow H, Aloj L, Aigbirhio F, Gurnell M. A Phase I/IIa Clinical Trial to Evaluate Safety and Adrenal Uptake of Para-Chloro-2-[18F]Fluoroethyletomidate in Healthy Volunteers and Patients with Primary Aldosteronism. J Nucl Med. 2025 Mar 3;66(3):434-440. doi: 10.2967/jnumed.124.268425.

Drugs

Indications