Pituitary Adenoma
Conditions
Brief 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.
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)
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of [18F]FET-PET/MRI | Baseline | Percentage of cases where surgical findings and pathology are concordant with \[18F\]FET-PET/MRI imaging |
Countries
United States
Contacts
CONTACTJulia Santos
PRINCIPAL_INVESTIGATORNeetu Soni, MBBS, MD
Mayo Clinic
Outcome results
None listed