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Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors

Who can join

All ages · All sexes

For Contrast Based Protocol:

Inclusion Criteria:

* Diagnosis of Cushing disease or required resection for non-corticotroph adenomas
* Agree to transsphenoidal resection.

Exclusion Criteria:

* Patients who are unable to consent (or if their legal guardian/representative decline to consent)
* Patients who have known or suspected hypersensitivity to microbubble contrast agents or its components such as polyethylene glycol (PEG).
* Women of child-bearing potential with a positive pregnancy test prior to procedure.
* Patients who have right to left, bi-directional, or transient right to left cardiac shunts.
* Patients who have hypersensitivity to perflutren.

For Non-Contrast Based Protocol:

Inclusion Criteria:

* Patients undergoing any pituitary surgery with the study designated neurosurgeons.
* Patients whose procedures require the use of an intra-operative BK ultrasound without contrast.

Exclusion Criteria:

• Patients who are unable to consent (or if their legal guardian/representative decline to consent)

About the study

This pilot and feasibility study aims to combine recent advances in ultrasound imaging, specifically an endonasal transducer array and contrast enhanced ultrasound, to offer an intraoperative image-guided solution for lesion-specific surgical resection to impact clinical outcome. Should this imaging approach help isolate specific lesions and prevent surgical resection of normal pituitary tissue in this first-in-humans study, then the results will provide clinical data for a much larger multi-center clinical trial.

What is being tested

• Contrast enhanced pituitary magnetic resonance imaging (MRI) (diagnostic test)
• Contrast enhanced ultrasound (diagnostic test)
• Non-Contrast Ultrasound (diagnostic test)

Sponsor: Mayo Clinic · Participants: 110 · Started: Jun 19, 2024

Contact the study team

• Neurologic Surgery Research Department · Phone: 507-293-7354
• Ian Mark, MD · Phone: 507-284-3211

Official record on ClinicalTrials.gov — NCT07335315

Locations in the U.S.

Conditions

• Pituitary Tumors
• Pituitary ACTH Hypersecretion

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.