Molecular Pituitary Imaging Using 18F-FET PET

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06584123
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Cambridge
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mark Gurnell, MD, PhD
Principal Investigator Affiliation	Cambridge University Hospitals NHS Foundation Trust
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pituitary Adenoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Study cohort

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

Interventions

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

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

James MacFarlane

[email protected]

01223 250882

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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