NCT07460232

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
24mo left

Started Apr 2026

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Jul 2028

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 27, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

1.9 years

First QC Date

March 4, 2026

Last Update Submit

June 17, 2026

Conditions

Cushing DiseasePituitary Adenoma

Outcome Measures

Primary Outcomes (3)

  • Sensitivity of FET PET results in comparison to histopathology

    Percentage of cases where surgical findings and pathology are in agreement with \[18F\]FET-PET/MRI imaging

    Baseline

  • Specificity of FET PET results in comparison to histopathology

    Baseline

  • Accuracy of FET PET results in comparison to histopathology

    Baseline

Secondary Outcomes (1)

  • Agreement of FET detection of ACTH-secreting pituitary with pituitary protocol MR

    Baseline

Study Arms (1)

(ACTH)-dependent Cushing disease

EXPERIMENTAL

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

Interventions

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

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.

(ACTH)-dependent Cushing disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Pituitary ACTH HypersecretionPituitary Neoplasms

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

HyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System Neoplasms

Study Officials

  • Derek Johnson, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brent Gessner, MBA

CONTACT

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

April 27, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)