FET-PET/MRI to locate small hormone-producing pituitary adenomas
Use of [18F] Fluoroethyl-L-tyrosine PET/MRI for Identifying Small Functional Pituitary Adenomas
This trial tests whether a special PET/MRI scan called FET-PET/MRI can find small hormone-producing pituitary adenomas in adults whose standard MRI is negative or unclear.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT07456878 on ClinicalTrials.gov |
What this trial studies
This Phase 1 protocol uses the investigational PET tracer 18F-fluoroethyl-L-tyrosine (FET) combined with MRI to try to identify small functional pituitary adenomas that are occult or equivocal on clinical dynamic contrast-enhanced MRI. Adults aged 18–75 with biochemically confirmed Cushing disease, acromegaly, or tumor-related hyperprolactinemia and a negative or unclear MRI will undergo FET-PET/MRI. Scans are reviewed for focal tracer uptake and the imaging results are used to inform clinical and surgical decision-making, including whether to proceed with targeted resection. Primary outcomes include diagnostic yield and the degree to which imaging changes management or surgical planning.
Who should consider this trial
Good fit: Adults 18–75 with biochemical confirmation of Cushing disease, acromegaly, or tumor-related hyperprolactinemia whose dynamic contrast MRI is negative or equivocal and who can undergo PET/MRI and are willing to have surgery if a lesion is found.
Not a fit: Patients with successful MRI localization of the adenoma, contraindications to MRI or PET (including pregnancy), or severe medical issues preventing imaging are unlikely to benefit.
Why it matters
Potential benefit: If successful, FET-PET/MRI could help locate tumors that standard MRI misses, enabling more targeted surgery and improved hormone control.
How similar studies have performed: Amino-acid PET tracers have shown promise in small case series for detecting occult pituitary lesions, but use of 18F-FET PET/MRI for this purpose is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 18 to 75 years of age with biochemically proven CD, Acromegaly, or tumor hyperprolactinemia as per current Endocrinology guidelines. * Clinical DCE-MRI protocol that is negative or equivocal for identifiable tumor. * Patient willing to have surgery if lesion found, or already scheduled for surgery and lesion identification would be helpful. * Able to provide informed consent and be capable of completing the imaging protocols. * Female subjects of childbearing potential (women of childbearing potential \[WOCBP\]) must have a negative urine pregnancy test ≤48 hours prior to the 18F-FET injection. Exclusion Criteria: * Patients with contraindications to MRI or PET scans. * Patients with known allergies to contrast agents or other imaging-related materials. * Patients with severe medical conditions that preclude participation in the study (e.g. inability to lie supine for 30-60 minutes). * Patients with successful MRI localization of the adenoma.
Where this trial is running
Jacksonville, Florida
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Neetu Soni, MBBS, MD — Mayo Clinic
- Study coordinator: Julia Santos
- Email: santos.julia@mayo.edu
- Phone: 904-953-3280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.