ClinicalTrials.gg
RecruitingNCT07460232Updated Oct 30, 2026

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

An Early Phase 1 interventional study of Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET in Cushing Disease and Pituitary Adenoma, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Mayo Clinic · Early Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Updated Oct 30, 2026Study contact changedGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cushing Disease
  • Pituitary Adenoma
03

In context

Pituitary ACTH Hypersecretion

64 studies on the registry are indexed under Pituitary ACTH Hypersecretion; 16 are open to participants now.

This study's planned enrollment of 50 is above the median of 44 across 40 interventional studies indexed under Pituitary ACTH Hypersecretion.

Browse Pituitary ACTH Hypersecretion studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 .

Exclusion criteria

Exclusion Criteria:

  • Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of
  • Declining to use effective 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 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 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 to any used in FET
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

Interventions

  • DrugFluoro-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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

  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

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

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    Recruiting
    • Casey R. McAdam, CCRP · Contact507-293-0505
    • Derek Johnson, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2026 (actual). Primary completion is estimated for Apr 2028, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 4, 2026
First posted
Mar 10, 2026
StartActual
Apr 27, 2026
Primary completionEst.
Apr 2028
CompletionEst.
Jul 2028
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Contact
Study contact changed: G•••@mayo.edu · •••2950→M•••@mayo.edu · •••0505. See the current contact
Oct 30, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Mayo Clinic in Rochester · Rochester, United StatesContact •••2950→•••0505
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Contact Study contact changed: G•••@mayo.edu · •••2950→M•••@mayo.edu · •••0505. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Mayo Clinic in Rochester · Rochester, United StatesContact •••2950→•••0505

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07460232
Lead sponsor
Mayo Clinic
Responsible party
Derek R. Johnson (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Mar 10, 2026
Start date
Apr 27, 2026
Primary completion
Apr 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Oct 30, 2026

Study contacts

Casey R McAdam, CCRP
Contact
McAdam.Casey@mayo.edu
507-293-0505
Derek Johnson, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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