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

NCT07456878 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 25-001207
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma

Outcome Measures

Primary Outcomes (1)

• Sensitivity of [18F]FET-PET/MRI

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

  Baseline

Study Arms (1)

FET-PET/MRI

EXPERIMENTAL

Patients who desire surgery and have active Cushing's Disease, Acromegaly, or tumoral hyperprolactinemia, occult tumor on DCE-MRI

Drug: FET-PET/MRI

Interventions

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)

Also known as: Fluoroethyl-L-tyrosine

FET-PET/MRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Neetu Soni, MBBS, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Santos

CONTACT

904-953-3280; santos.julia@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 9, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)