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RECRUITINGPhase 1INTERVENTIONAL

Use of [18F] Fluoroethyl-L-tyrosine PET/MRI for Identifying Small Functional Pituitary Adenomas

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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