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RecruitingInterventionalPhase 1
Use of [18F] Fluoroethyl-L-tyrosine PET/MRI for Identifying Small Functional Pituitary Adenomas
NCT ID: NCT07456878Sponsor: Mayo ClinicLast updated: 2026-03-09
Summary
The purpose of this research is to evaluate the diagnostic role and clinical efficacy of investigational FET-PET/MRI in detecting MRI-occult primary or residual/recurrent functional pituitary adenomas (PAs) and its influence on clinical and surgical decisions.
Arms & interventions
- DrugFET-PET/MRI
Patients will undergo PET/MR scan after intravenous administration of 5 mCi ± 0.5 mCi of Fluoroethyl-L-tyrosine (\[18F\]FET)
Outcome measures
Primary
Sensitivity of [18F]FET-PET/MRI
Percentage of cases where surgical findings and pathology are concordant with \[18F\]FET-PET/MRI imaging
Time frame: Baseline
Eligibility criteria
Sex: AllAge: 18 Years to 75 YearsHealthy volunteers: No
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.
Study locations (1)
Mayo Clinic
Jacksonville, Florida, 32224
Neetu Soni, MBBS, MD · Principal Investigator