Cushing Disease, Pituitary Adenoma
Conditions
Brief summary
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
DRUGFluoro-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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of FET PET results in comparison to histopathology | 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 | Baseline | — |
| Accuracy of FET PET results in comparison to histopathology | Baseline | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement of FET detection of ACTH-secreting pituitary with pituitary protocol MR | Baseline | Percentage of cases where pituitary protocol MR results are in agreement with FET-PET imaging |
Countries
United States
Contacts
CONTACTBrent Gessner, MBA
PRINCIPAL_INVESTIGATORDerek Johnson, MD
Mayo Clinic
Outcome results
None listed