FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease

Mayo Clinic

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Cushing Disease

Pituitary Adenoma

Treatments

Drug: Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET

Study type

Interventional

Funder types

Other

Identifiers

NCT07460232

22-006092

Details and patient eligibility

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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