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FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease | Clinical Trials | Clareo Health

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FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease

18Fluoro-O-(2) Fluoroethyl-L-tyrosine (FET) PET For Localization Of Pituitary Adenomas In Patients With Cushing Disease

NCT07460232•Mayo Clinic

Summary

The purpose of this research is to evaluate the performance \[sensitivity, specificity, accuracy\] of FET PET/CT imaging to detect ACTH-secreting pituitary adenoma, using operative findings and histopathology as truth standard.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must meet ALL criteria listed below for entry:
•Biochemically diagnosed ACTH-dependent Cushing disease.
•No previous pituitary surgery.
•Planned to undergo pituitary surgery for localization/resection of adenoma.
•No contraindications for PET/CT.
•Recent (within 3 months) pituitary MR, or pending pituitary MR to be performed as close as possible to FET PET/CT.
•Age ≥ 18 years.
•Ability to provide informed consent.

Exclusion Criteria

•Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
•Declining to use effective contraceptive methods during the study (for individuals of child-bearing potential)
•Need for emergent surgery that would be delayed by participation
•Bacterial, viral, or fungal infections requiring systemic therapy
•Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator could compromise patient safety and/or protocol objectives
•Known diagnosis of autoimmune disorders
•Patients receiving any other investigational agent within the past 28 days
•Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the FET injection.
•Known hypersensitivity to any excipients used in FET

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

April 1, 2026

Primary Completion Date

April 1, 2028

Completion Date

July 1, 2028

Last Updated

March 10, 2026

Enrollment

ESTIMATED participants

Conditions

Cushing DiseasePituitary Adenoma

Interventions

Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET

DRUG

Contacts

Brent Gessner, MBA

CONTACT

507-284-2950 Gessner.Brent@mayo.edu

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease

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Exclusion Criteria

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