Pituitary AdenomaFET-pit-PETNCT06584123
Molecular Pituitary Imaging Using 18F-FET PET
A study testing 18F-Fluoro-ethyl-tyrosine (FET) PET in people with Pituitary Adenoma, run by University of Cambridge at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- 18F-Fluoro-ethyl-tyrosine (FET) PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Sep 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals
Cambridge, Cambridgeshire, CB2 0QQ
Mark Gurnell, PhD FRCP, +44-1223-245151, mark.gurnell2@nhs.net
Mark Gurnell, PhD FRCP
About this study
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)
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.
Read the 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.
- Conditions
- Pituitary Adenoma
- Being tested
- 18F-Fluoro-ethyl-tyrosine (FET) PET
- Keywords
- Molecular pituitary imaging, Functional pituitary imaging, 18F-FET PET
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Fluoro-ethyl-tyrosine (FET) PETDiagnostic test
18F-Fluoro-ethyl-tyrosine PET study of the pituitary
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Experimental | All patient's enrolled in the study will undergo an 18F-FET-PET Receives: Diagnostic Test: 18F-Fluoro-ethyl-tyrosine (FET) PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Comparison of maximum Standardized Uptake Values (SUVmax) measured over normal pituitary gland and parasellar structures (e.g. cavernous sinuses) on each type of PET scan.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start3 Sep 2024
- Primary completion2 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Professor Mark Gurnell, University of Cambridge
- Investigators
- Mark Gurnell, MD, PhD, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584123
- Sponsor's protocol ID
- 24/LO/0542
- Acronym
- FET-pit-PET
- Status last verified
- Jan 2026
- First submitted
- 24 Jul 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32741476Koulouri 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.
PubMed 27562400Koulouri 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.
PubMed 26245763Koulouri 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.
PubMed 27777050Bashari 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.
PubMed 32480379Grosu 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.
PubMed 21570201Currie 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.
PubMed 24948822van 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.
PubMed 21296442
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06584123
- Acronym / sponsor ID
- FET-pit-PET / 24/LO/0542
- Conditions
- Pituitary Adenoma
- Keywords
- Molecular pituitary imaging, Functional pituitary imaging, 18F-FET PET
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 2 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Study cohort | Experimental | Diagnostic Test: 18F-Fluoro-ethyl-tyrosine (FET) PETAll patient's enrolled in the study will undergo an 18F-FET-PET |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-Fluoro-ethyl-tyrosine (FET) PET18F-Fluoro-ethyl-tyrosine PET study of the pituitary | Diagnostic test | Study cohort |
Primary outcome
Maximum Standardized Uptake Values (SUVmax) over pituitary tumour on each of 11C-methionine and 18F-fluoroethyltyrosine PET scans
Time frame: 1 day
Comparison of maximum Standardized Uptake Values (SUVmax) measured over pituitary tumours on each type of PET scan.
1 secondary outcome
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
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Background: PubMed 32741476MacFarlane 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.
- Background: PubMed 27562400Koulouri 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.
- Background: PubMed 26245763Koulouri 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.
- Background: PubMed 27777050Koulouri 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.
- Background: PubMed 32480379Bashari 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.
- Background: PubMed 21570201Grosu 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.
- Background: PubMed 24948822Currie 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.
- Background: PubMed 21296442van 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.
- Individual participant dataSharing planned: No
Related trials for Pituitary Adenoma
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Recruiting
Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery
Pituitary Neoplasm
Active, not recruitingPhase 2
Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy
Radiation of Neurocranial Region
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
RecruitingEarly Phase 1
Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
Meningioma, Glioblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Gurnell, MD, PhD principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-Fluoro-ethyl-tyrosine (FET) PET in people with Pituitary Adenoma, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James MacFarlane (01223 250882, jm2267@medschl.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Standardized Uptake Values (SUVmax) over pituitary tumour on each of 11C-methionine and 18F-fluoroethyltyrosine PET scans (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06584123, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.