Actively Recruiting
18Fluoro-O-(2) Fluoroethyl-L-tyrosine (FET) PET For Localization Of Pituitary Adenomas In Patients With Cushing Disease
Led by Mayo Clinic · Updated on 2026-05-29
50
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of FET PET/CT imaging to locate ACTH-secreting pituitary adenomas in patients diagnosed with ACTH-dependent Cushing disease. This early phase 1 interventional study aims to measure how accurately this imaging technique detects pituitary adenomas, using surgical findings and tissue analysis as the standard for comparison. Participants will receive an intravenous dose of radiolabeled Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) approximately 20 minutes before undergoing a PET/CT scan focused on the head and neck area around the pituitary gland. The study involves patients who are candidates for pituitary surgery to remove adenomas. The imaging results will be compared to histopathology and pituitary MRI findings to assess sensitivity, specificity, and accuracy. During the study, participants will undergo the FET PET/CT imaging and provide consent for use of their surgical and histopathological data. The main outcomes measured include how well the FET PET detects adenomas compared to tissue analysis and MRI. Safety and adherence are monitored, with follow-up as needed. The study is expected to run until July 2028, involving adults aged 18 and older with Cushing disease.
CONDITIONS
Brief Title
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biochemically diagnosed ACTH-dependent Cushing disease
- No previous pituitary surgery
- Planned to undergo pituitary surgery for localization or removal of adenoma
- No contraindications for PET/CT imaging
- Recent or pending pituitary MRI performed close to the FET PET/CT
- Age 18 years or older
- Ability to provide informed consent
You will not qualify if you...
- Pregnant individuals as determined by pregnancy test
- Declining to use effective contraception during the study (if of child-bearing potential)
- Need for emergency surgery that would be delayed by study participation
- Active bacterial, viral, or fungal infections requiring systemic treatment
- Serious co-morbid or nonmalignant diseases compromising safety or study goals
- Known autoimmune disorders
- Use of other investigational agents within 28 days prior to study
- Breastfeeding without commitment to discard milk for 24 hours after injection
- Known hypersensitivity to any ingredients in the FET agent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive an intravenous injection of radiolabeled FET followed by a PET/CT scan focused on the pituitary gland to localize adenomas.
1 visit (in-person)
Duration - Up to the time of surgery, typically a few weeks
Participants are observed following the imaging evaluation as they proceed to planned pituitary surgery.
Visits as needed based on clinical care
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
B
Brent Gessner, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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