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Taking people in United StatesEarly phase 1

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

Key facts

Who runs it
Mayo Clinic
Where
Rochester, United StatesSee the site
Trial code
Status
Recruiting
Phase
Early phase 1
People taking part
50 people, planned
Started
27 Apr 2026
Expected to end
Jul 2028
Type of study
Interventional
Treatments tested
  • Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET
Record updated
30 October 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Need for emergent surgery that would be delayed by participation
  • Patients receiving any other investigational agent within the past 28 days
  • 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
  • Known hypersensitivity to any excipients used in FET
  • 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)
  • 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

Where in United States

  • Mayo Clinic in RochesterRochester, United StatesContact: Casey R. McAdam, CCRPTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • (ACTH)-dependent Cushing diseaseTreatment being tested

    Patients with adrenocorticotropic hormone (ACTH)-dependent Cushing disease who may be considered candidates for surgical treatment

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
18Fluoro-O-(2) Fluoroethyl-L-tyrosine (FET) PET For Localization Of Pituitary Adenomas In Patients With Cushing Disease
Record updated
30 October 2026