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NCT Number: NCT07456878

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

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.

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Key information

Conditions

Pituitary Adenoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pituitary Diseases Pituitary Neoplasms Supratentorial Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Julia Santos

CONTACT

904-953-3280

Neetu Soni, MBBS, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FET-PET/MRI

Drug

Patients will undergo PET/MR scan after intravenous administration of 5 mCi ± 0.5 mCi of Fluoroethyl-L-tyrosine ([18F]FET)

Other names: Fluoroethyl-L-tyrosine

Primary outcomes

Sensitivity of [18F]FET-PET/MRI

Time frame: Baseline

Percentage of cases where surgical findings and pathology are concordant with [18F]FET-PET/MRI imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Julia Santos

CONTACT

[email protected]

904-953-3280

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Mar 9, 2026
Registry last updated: Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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