- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06584123
Molecular Pituitary Imaging Using 18F-FET PET (FET-pit-PET)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: James MacFarlane
- Phone Number: 01223 250882
- Email: jm2267@medschl.cam.ac.uk
Study Locations
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
- Recruiting
- Cambridge University Hospitals
-
Contact:
- Mark Gurnell, PhD FRCP
- Phone Number: +44-1223-245151
- Email: mark.gurnell2@nhs.net
-
Principal Investigator:
- Mark Gurnell, PhD FRCP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study cohort
All patient's enrolled in the study will undergo an 18F-FET-PET
|
18F-Fluoro-ethyl-tyrosine PET study of the pituitary
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Gurnell, MD, PhD, Cambridge University Hospitals NHS Foundation Trust
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Endocrine Gland Neoplasms
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Hypothalamic Diseases
- Hypothalamic Neoplasms
- Supratentorial Neoplasms
- Brain Neoplasms
- Pituitary Diseases
- Pituitary Neoplasms
Other Study ID Numbers
- 24/LO/0542
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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