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NCT Number: NCT07460232

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Brent Gessner

CONTACT

507-284-2950

Derek Johnson, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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 outcomes

  1. 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

  2. Specificity of FET PET results in comparison to histopathology

    Time frame: Baseline

  3. Accuracy of FET PET results in comparison to histopathology

    Time frame: Baseline

Secondary outcomes

  1. Agreement of FET detection of ACTH-secreting pituitary with pituitary protocol MR

    Time frame: Baseline

    Percentage of cases where pituitary protocol MR results are in agreement with FET-PET imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Brent Gessner, MBA

CONTACT

[email protected]

507-284-2950

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

18Fluoro-O-(2) Fluoroethyl-L-tyrosine (FET) PET For Localization Of Pituitary Adenomas In Patients With Cushing Disease

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 10, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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