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Clinical Trials/NCT07456878
NCT07456878RecruitingPhase 1

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

Mayo Clinic1 site in 1 country5 target enrollmentStarted: January 8, 2026Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Enrollment
5
Locations
1
Primary Endpoint
Sensitivity of [18F]FET-PET/MRI
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

FET-PET/MRI

Experimental

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

Intervention: FET-PET/MRI (Drug)

Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Neetu Soni

Principal Investigator

Mayo Clinic

Study Sites (1)

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