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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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