NCT06584123

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Sep 2024Dec 2026

First Submitted

Initial submission to the registry

July 24, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 3, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

July 24, 2024

Last Update Submit

January 5, 2026

Conditions

Keywords

Molecular pituitary imagingFunctional pituitary imaging18F-FET PET

Outcome Measures

Primary Outcomes (1)

  • Maximum Standardized Uptake Values (SUVmax) over pituitary tumour on each of 11C-methionine and 18F-fluoroethyltyrosine PET scans

    Comparison of maximum Standardized Uptake Values (SUVmax) measured over pituitary tumours on each type of PET scan.

    1 day

Secondary Outcomes (1)

  • 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

    1 day

Study Arms (1)

Study cohort

EXPERIMENTAL

All patient's enrolled in the study will undergo an 18F-FET-PET

Diagnostic Test: 18F-Fluoro-ethyl-tyrosine (FET) PET

Interventions

18F-Fluoro-ethyl-tyrosine PET study of the pituitary

Study cohort

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University Hospitals

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Related Publications (8)

  • 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.

    PMID: 32741476BACKGROUND
  • 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.

    PMID: 27562400BACKGROUND
  • 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.

    PMID: 26245763BACKGROUND
  • 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.

    PMID: 27777050BACKGROUND
  • 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.

    PMID: 32480379BACKGROUND
  • 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.

    PMID: 21570201BACKGROUND
  • 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.

    PMID: 24948822BACKGROUND
  • 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.

    PMID: 21296442BACKGROUND

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Mark Gurnell, MD, PhD

    Cambridge University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Endocrinology

Study Record Dates

First Submitted

July 24, 2024

First Posted

September 4, 2024

Study Start

September 3, 2024

Primary Completion (Estimated)

September 2, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations