Recruiting
Phase 1

FET-PET/MRI

Sponsor:

Mayo Clinic

Code:

NCT07456878

Conditions

Pituitary Adenoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

FET-PET/MRI

Study Details

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

Study ID

NCT07456878

Start date

Jan 8, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: FET-PET/MRI

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

Interventions

FET-PET/MRI

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

Primary outcome measure

  • Sensitivity of [18F]FET-PET/MRI [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Julia Santos

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

Locations

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Julia Santos

904-953-3280

Principal Investigator:

Neetu Soni, MBBS, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-09.