What this study is
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.
What's being tested
- Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET
Intervention · DRUG
Patients will receive intravenous administration of radiolabeled FET (5mCi ±10%) administered 20 minutes (±10minutes) prior to the initiation of the attenuation correction CT followed by the PET acquisition encompassing the participant's head/neck, centered on the pituitary gland.
Study details
- Official title
- 18Fluoro-O-(2) Fluoroethyl-L-tyrosine (FET) PET For Localization Of Pituitary Adenomas In Patients With Cushing Disease
- Sponsor
- Mayo Clinic
- Conditions
- Cushing Disease · Pituitary Adenoma
- Enrolling
- 50 people
- Starts
- 2026-04-27
- Est. completion
- 2028-07
- Design
- Open-label, single group, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
- BreastfeedingExcept: 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic in Rochester
Rochester, Minnesota, United States
- Casey R. McAdam, CCRP · Contact507-293-0505
- Derek Johnson, MD · Principal investigator
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 22-006092
Principal investigator
Derek Johnson, MD
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.