RECRUITINGPhase 1INTERVENTIONAL
Use of [18F] Fluoroethyl-L-tyrosine PET/MRI for Identifying Small Functional Pituitary Adenomas
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
FET-PET/MRI
Patients will undergo PET/MR scan after intravenous administration of 5 mCi ± 0.5 mCi of Fluoroethyl-L-tyrosine (\[18F\]FET)
Locations (1)
Mayo Clinic
Jacksonville, Florida, United States