NCT07460232 FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
| NCT ID | NCT07460232 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Mayo Clinic |
| Condition | Cushing Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2026-04-27 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Derek Johnson, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07460232 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cushing Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07460232 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07460232 currently recruiting?
Yes, NCT07460232 is actively recruiting participants. Contact the research team at Gessner.Brent@mayo.edu for enrollment information.
Where is the NCT07460232 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07460232 clinical trial?
NCT07460232 is sponsored by Mayo Clinic. The principal investigator is Derek Johnson, MD at Mayo Clinic. The trial plans to enroll 50 participants.