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
Conditions
Pituitary AdenomaCushing Disease
Locations
Mayo Clinic
Rochester, Minnesota 55905
United States