FET-PET/MRI to locate small hormone-producing pituitary adenomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 protocol uses the investigational PET tracer 18F-fluoroethyl-L-tyrosine (FET) combined with MRI to try to identify small functional pituitary adenomas that are occult or equivocal on clinical dynamic contrast-enhanced MRI. Adults aged 18–75 with biochemically confirmed Cushing disease, acromegaly, or tumor-related hyperprolactinemia and a negative or unclear MRI will undergo FET-PET/MRI. Scans are reviewed for focal tracer uptake and the imaging results are used to inform clinical and surgical decision-making, including whether to proceed with targeted resection. Primary outcomes include diagnostic yield and the degree to which imaging changes management or surgical planning.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients 18 to 75 years of age with biochemically proven CD, Acromegaly, or tumor hyperprolactinemia as per current Endocrinology guidelines.
* Clinical DCE-MRI protocol that is negative or equivocal for identifiable tumor.
* Patient willing to have surgery if lesion found, or already scheduled for surgery and lesion identification would be helpful.
* Able to provide informed consent and be capable of completing the imaging protocols.
* Female subjects of childbearing potential (women of childbearing potential \[WOCBP\]) must have a negative urine pregnancy test ≤48 hours prior to the 18F-FET injection.

Exclusion Criteria:

* Patients with contraindications to MRI or PET scans.
* Patients with known allergies to contrast agents or other imaging-related materials.
* Patients with severe medical conditions that preclude participation in the study (e.g. inability to lie supine for 30-60 minutes).
* Patients with successful MRI localization of the adenoma.

Where it's running

• Mayo Clinic
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Neetu Soni, MBBS, MD — Mayo Clinic
• Study coordinator: Julia Santos
• Email: santos.julia@mayo.edu
• Phone: 904-953-3280

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.