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FET PET/CT Imaging for Pituitary Adenomas in Cushing Disease

This study is looking at how well a special imaging test, called Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET/CT, can find pituitary adenomas (small growths on the pituitary gland) in people with Cushing disease. Cushing disease is caused by too much of a hormone called ACTH. You might be able to join if you have Cushing disease that's been diagnosed by blood tests, haven't had pituitary surgery before, and are planning to have surgery to remove the adenoma. The researchers will compare the FET PET/CT results to what doctors find during surgery and from examining the removed tissue. The goal is to see how accurate this imaging test is. The current status of this study is unclear, and it plans to enroll 50 participants.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 50 participants.
What's involved
You would receive an intravenous (into a vein) injection of radiolabeled FET about 20 minutes before a PET/CT scan of your head and neck. You will also need a recent pituitary MRI or one performed close to the FET PET/CT.
Compensation
Not stated in the trial record.
Follow-up
The main results are measured at baseline, which means at the start of the study when the imaging and surgery are performed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07460232

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
Mayo Clinic
~50 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity of FET PET results in comparison to histopathology
Measured over Baseline
+2 more outcomes measured

Conditions

Cushing Disease
Pituitary Adenoma

Explore related trials

Cushing DiseasePituitary Neuroendocrine Tumor

NCT07460232

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Derek Johnson, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Brent Gessner, MBA
[email protected]
507-284-2950
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Sensitivity of FET PET results in comparison to histopathologyBaseline

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

  • Specificity of FET PET results in comparison to histopathologyBaseline
  • Accuracy of FET PET results in comparison to histopathologyBaseline