Clinical trial NCT06584123: Molecular Pituitary Imaging Using 18F-FET PET
Official title: Exploring the Potential for 18F-fluoro-ethyl-tyrosine (18F-FET) to Enable Wider Access to Molecular Imaging for Patients With Pituitary Adenomas (FET-pit-PET Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pituitary Adenoma
Keywords: Molecular pituitary imaging
Functional pituitary imaging
18F-FET PET
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: Cambridge University Hospitals NHS Foundation Trust
First posted: 2024-09-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient's who have previously undergone 11C-Methionine PET during routine clinical care will be invited to undergo 18F-Fluoro-ethyl-tyrosine PET (FET PET).
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this single centre pilot study is to explore whether 18F-fluoro-ethyl-tyrosine PET (FET-PET) yields comparable findings to 11C-methionine PET (Met-PET) for the localisation of pituitary tumours.

Detailed description: Up to 20 patients with pituitary adenomas (PA) who have previously undergone 11C-methionine PET (Met-PET) as part of routine clinical care will undergo 18F-fluoroethyltyrosine PET (FET-PET). Patients with newly diagnosed PA or residual/recurrent pituitary tumours following previous treatment will be eligible for recruitment to the study.

Quantitative and qualitative analyses will be performed to assess whether MET-PET and FET-PET yield comparable findings in patients with newly diagnosed or recurrent PA.

Eligibility criteria: Inclusion criteria

* Participant is willing and able to give informed consent for participation in the study
* Male or female, age 18 or above
* Presence of pituitary adenoma suspected on the basis of clinical/biochemical and/or radiological findings
* Previous 11C-Met-PET/CT

Exclusion criteria

* Inability to give informed consent
* Pregnancy or suspected pregnancy
* Inability to lie supine for 30-60 minutes
* Patient body habitus above scanner dimensions
* Known allergy to intravenous radiographic contrast agents

Primary outcomes:
measure: Maximum Standardized Uptake Values (SUVmax) over pituitary tumour on each of 11C-methionine and 18F-fluoroethyltyrosine PET scans
timeFrame: 1 day
Secondary outcomes:
measure: Maximum Standardized Uptake Values (SUVmax) over normal pituitary gland and parasellar structures (e.g. cavernous sinuses) on each of 11C-methionine and 18F-fluoroethyltyrosine PET scans
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Mark Gurnell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacFarlane J, Bashari WA, Senanayake R, Gillett D, van der Meulen M, Powlson AS, Kolias A, Koulouri O, Gurnell M. Advances in the Imaging of Pituitary Tumors. Endocrinol Metab Clin North Am. 2020 Sep;49(3):357-373. doi: 10.1016/j.ecl.2020.06.002. Epub 2020 Jul 15.
citation: Koulouri O, Kandasamy N, Hoole AC, Gillett D, Heard S, Powlson AS, O'Donovan DG, Annamalai AK, Simpson HL, Akker SA, Aylwin SJ, Brooke A, Buch H, Levy MJ, Martin N, Morris D, Parkinson C, Tysome JR, Santarius T, Donnelly N, Buscombe J, Boros I, Smith R, Aigbirhio F, Antoun NM, Burnet NG, Cheow H, Mannion RJ, Pickard JD, Gurnell M. Successful treatment of residual pituitary adenoma in persistent acromegaly following localisation by 11C-methionine PET co-registered with MRI. Eur J Endocrinol. 2016 Nov;175(5):485-498. doi: 10.1530/EJE-16-0639. Epub 2016 Aug 25.
citation: Koulouri O, Steuwe A, Gillett D, Hoole AC, Powlson AS, Donnelly NA, Burnet NG, Antoun NM, Cheow H, Mannion RJ, Pickard JD, Gurnell M. A role for 11C-methionine PET imaging in ACTH-dependent Cushing's syndrome. Eur J Endocrinol. 2015 Oct;173(4):M107-20. doi: 10.1530/EJE-15-0616. Epub 2015 Aug 5.
citation: Koulouri O, Hoole AC, English P, Allinson K, Antoun N, Cheow H, Burnet NG, Donnelly N, Mannion RJ, Gurnell M. Localisation of an occult thyrotropinoma with 11C-methionine PET-CT before and after somatostatin analogue therapy. Lancet Diabetes Endocrinol. 2016 Dec;4(12):1050. doi: 10.1016/S2213-8587(16)30311-4. Epub 2016 Oct 21. No abstract available.
citation: Bashari WA, Senanayake R, Koulouri O, Gillett D, MacFarlane J, Powlson AS, Fernandez-Pombo A, Bano G, Martin AJ, Scoffings D, Cheow H, Mendichovszky I, Tysome J, Donnelly N, Santarius T, Kolias A, Mannion R, Gurnell M. PET-guided repeat transsphenoidal surgery for previously deemed unresectable lateral disease in acromegaly. Neurosurg Focus. 2020 Jun;48(6):E8. doi: 10.3171/2020.3.FOCUS2052.
citation: Grosu AL, Astner ST, Riedel E, Nieder C, Wiedenmann N, Heinemann F, Schwaiger M, Molls M, Wester HJ, Weber WA. An interindividual comparison of O-(2-[18F]fluoroethyl)-L-tyrosine (FET)- and L-[methyl-11C]methionine (MET)-PET in patients with brain gliomas and metastases. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):1049-58. doi: 10.1016/j.ijrobp.2010.07.002. Epub 2011 May 11.
citation: Currie GM, Trifunovic M, Kiat H, Saunders C, Chung D, Ong YY, Wilkinson M, Witte K, Magnussen J. Pituitary incidentaloma found on O-(2-18F-fluoroethyl)-l-tyrosine PET. J Nucl Med Technol. 2014 Sep;42(3):218-22. doi: 10.2967/jnmt.113.136291. Epub 2014 Jun 19.
citation: van den Bergh AC, Pruim J, Links TP, van der Vliet AM, Sluiter W, Wolffenbuttel BH, Langendijk JA, Hoving EW, Dullaart RP. Tyrosine positron emission tomography and protein synthesis rate in pituitary adenoma: different effects of surgery and radiation therapy. Radiother Oncol. 2011 Feb;98(2):213-6. doi: 10.1016/j.radonc.2010.12.020. Epub 2011 Feb 4.