NCT07460232 · Mayo Clinic
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET
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.
Primary outcome measures
Sensitivity of FET PET results in comparison to histopathology
Time frame: Baseline
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 histopathology
Time frame: Baseline
Accuracy of FET PET results in comparison to histopathology
Time frame: Baseline
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
Where
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations