Use of [18F] Fluoroethyl-L-tyrosine PET/MRI for Identifyi... | NCT07456878

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

NCT07456878

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Mar 9, 2026Actual

Enrollment

5Estimated

Phase

Phase 1

Conditions

Pituitary Adenoma

Interventions

FET-PET/MRI

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2026Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Mar 3, 2026

First Submission Date that Met QC Criteria

Mar 3, 2026

First Posted Date

Mar 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2026

Last Update Posted Date

Mar 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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)	FET-PET/MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity of [18F]FET-PET/MRI	Percentage of cases where surgical findings and pathology are concordant with [18F]FET-PET/MRI imaging	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Julia Santos	Contact	904-953-3280		santos.julia@mayo.edu

Overall Officials

Name	Affiliation	Role
Neetu Soni, MBBS, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic	Recruiting	Jacksonville	Florida	32224	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010911	Pituitary Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D007029	Hypothalamic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided