Cushing DiseaseEarly Phase 1NCT07460232
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
A Early Phase 1 study testing Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET in people with Cushing Disease and Pituitary Adenoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing Disease, Pituitary Adenoma
- What is being tested?
- Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2026to Jul 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Casey R. McAdam, CCRP, 507-293-0505
Derek Johnson, MD
About this study
Official title: 18Fluoro-O-(2) Fluoroethyl-L-tyrosine (FET) PET For Localization Of Pituitary Adenomas In Patients With 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.
- Conditions
- Cushing Disease, Pituitary Adenoma
- Being tested
- Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET
- Medical subject headings
- Pituitary ACTH Hypersecretion, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| (ACTH)-dependent Cushing disease | Experimental | Patients with adrenocorticotropic hormone (ACTH)-dependent Cushing disease who may be considered candidates for surgical treatment Receives: Drug: Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Specificity of FET PET results in comparison to histopathology
Measured: Baseline
Accuracy of FET PET results in comparison to histopathology
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start27 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek R. Johnson, Mayo Clinic
- Investigators
- Derek Johnson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460232
- Sponsor's protocol ID
- 22-006092
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18Fluoro-O-(2) Fluoroethyl-L-tyrosine (FET) PET For Localization Of Pituitary Adenomas In Patients With Cushing Disease
- ClinicalTrials.gov ID
- NCT07460232
- Acronym / sponsor ID
- 22-006092
- Conditions
- Cushing Disease, Pituitary Adenoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (ACTH)-dependent Cushing disease | Experimental | Drug: Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PETPatients with adrenocorticotropic hormone (ACTH)-dependent Cushing disease who may be considered candidates for surgical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PETPatients 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. | Drug | (ACTH)-dependent Cushing disease |
Primary outcome
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
Specificity of FET PET results in comparison to histopathology
Time frame: Baseline
Accuracy of FET PET results in comparison to histopathology
Time frame: Baseline
1 secondary outcome
Agreement of FET detection of ACTH-secreting pituitary with pituitary protocol MR
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Derek Johnson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET in people with Cushing Disease and Pituitary Adenoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Casey R McAdam, CCRP (507-293-0505, McAdam.Casey@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of FET PET results in comparison to histopathology (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.