RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

For Contrast Based Protocol: Who May Qualify: - Diagnosis of Cushing disease or required resection for non-corticotroph adenomas - Agree to transsphenoidal resection. Who Should NOT Join This Trial: - 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: Who May Qualify: - Patients undergoing any pituitary surgery with the study designated neurosurgeons. - Patients whose procedures require the use of an intra-operative BK ultrasound without contrast. Who Should NOT Join This Trial: • Patients who are unable to consent (or if their legal guardian/representative decline to consent) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

DIAGNOSTIC_TEST

Contrast enhanced pituitary magnetic resonance imaging (MRI)

Pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound.

DIAGNOSTIC_TEST

Contrast enhanced ultrasound

Contrast enhanced intraoperative ultrasound imaging with Definity microbubbles that will be activated per the manufacturer specification and administered as a bolus of 0.2 mL of perflutren lipid microsphere intravenously followed by a 10 mL flush of saline. The pituitary will be imaged in the transverse plane for 2 minutes following this bolus. A repeat injection of the same ultrasound contrast dose and saline flush will be performed, and the pituitary will be imaged in the sagittal plane for 2 minutes.

DIAGNOSTIC_TEST

Non-Contrast Ultrasound

Intra-operative ultrasound without contrast for pituitary adenomas and MRI

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States