Fluid-based PET imaging to locate ACTH-secreting pituitary adenomas in Cushing disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early phase1 (pilot) study evaluates the sensitivity, specificity, and overall accuracy of Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET/CT imaging to localize ACTH-secreting pituitary adenomas. Participants are adults with biochemically confirmed ACTH-dependent Cushing disease who have no prior pituitary surgery and are scheduled for surgical localization or resection; they will undergo FET PET/CT preoperatively and results will be compared against operative findings and histopathology as the reference standard. The trial is conducted at Mayo Clinic, Rochester, and requires recent or pending pituitary MRI and no contraindications to PET/CT. Safety considerations include standard imaging risks and exclusion of pregnant individuals or those with certain infections or serious co-morbidities. The primary aim is to determine how well FET PET/CT can pinpoint the adenoma to aid surgical planning.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Derek Johnson, MD — Mayo Clinic
• Study coordinator: Casey R McAdam, CCRP
• Email: McAdam.Casey@mayo.edu
• Phone: 507-293-0505

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using [18F]FET PET to find ACTH-secreting pituitary microadenomas

  This project tests whether [18F]FET PET scans can better locate ACTH-secreting pituitary microadenomas in adults with Cushing's disease.

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• FET-PET/MRI to locate small hormone-producing pituitary adenomas

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.