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.
Diagnosis of Cushing disease or required resection for non-corticotroph adenomas
Agree to transsphenoidal resection.
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 with a pituitary adenoma or lesion that will undergo transnasal surgery
Cohort
Prospective
Contrast enhanced pituitary magnetic resonance imaging (MRI)
Diagnostic testPre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound.
Contrast enhanced ultrasound
Diagnostic testContrast 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.
Non-Contrast Ultrasound
Diagnostic testIntra-operative ultrasound without contrast for pituitary adenomas and MRI
Scoring of non-contrast ultrasound images
Non-contrast ultrasound images will be evaluated by a board certified neuroradiologists with experience reviewing pituitary imaging. The ultrasound images will be scored on the identification, size, location, echogenicity, and enhancement of any potential pituitary lesions as well as a confidence level in identifying the adenoma (1-5 Likert scale) with 1 being non-diagnostic/poor and 5 being excellent/diagnostic quality.
Scoring of contrast-enhanced ultrasound images
Contrast-enhanced ultrasound images will be evaluated by a board certified neuroradiologists with experience reviewing pituitary imaging. The ultrasound images will be scored on the identification, size, location, echogenicity, and enhancement of any potential pituitary lesions as well as a confidence level in identifying the adenoma (1-5 Likert scale) with 1 being non-diagnostic/poor and 5 being excellent/diagnostic quality.
Scoring of pituitary MRI images
Preoperative Research Pituitary MRI images will be evaluated by a board certified neuroradiologists with experience reviewing pituitary imaging. The MRI images will be scored on the identification, size, location, echogenicity, and enhancement of any potential pituitary lesions as well as a confidence level in identifying the adenoma (1-5 Likert scale) with 1 being non-diagnostic/poor and 5 being excellent/diagnostic quality.
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Mayo Clinic
Lead sponsor
American Society of Head and Neck Radiology
Collaborator
GE Healthcare
Collaborator
Lantheus Medical Imaging
Collaborator
