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

Purpose

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.

Conditions

  • Cushing Disease
  • Pituitary Adenoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
(ACTH)-dependent Cushing disease
Patients with adrenocorticotropic hormone (ACTH)-dependent Cushing disease who may be considered candidates for surgical treatment
  • 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.

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Brent Gessner
507-284-2950

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Brent Gessner, MBA
507-284-2950
Gessner.Brent@mayo.edu