Recruiting
Early Phase 1

FET PET/CT

Sponsor:

Mayo Clinic

Code:

NCT07460232

Conditions

Cushing Disease

Pituitary Adenoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Cushing Disease

Pituitary Adenoma

Study ID

NCT07460232

Start date

Apr 27, 2026

Status verified date

Jun, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: (ACTH)-dependent Cushing disease

Patients with adrenocorticotropic hormone (ACTH)-dependent Cushing disease who may be considered candidates for surgical treatment

Interventions

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 measure

  • Sensitivity of FET PET results in comparison to histopathology [ Time Frame: Baseline ]
  • Specificity of FET PET results in comparison to histopathology [ Time Frame: Baseline ]
  • Accuracy of FET PET results in comparison to histopathology [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Brent Gessner, MBA

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Brent Gessner

507-284-2950

Principal Investigator:

Derek Johnson, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-22.