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NCT07335315Recruiting

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

Mayo Clinic

Start Date

6/19/2024

Completion Date

1/1/2027

Summary

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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)

Interventions

DIAGNOSTIC_TEST

Contrast enhanced pituitary magnetic resonance imaging (MRI)

DIAGNOSTIC_TEST

Contrast enhanced ultrasound

DIAGNOSTIC_TEST

Non-Contrast Ultrasound

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Conditions

Pituitary AdenomaCushing Disease

Locations

Mayo Clinic

Rochester, Minnesota 55905

United States