RecruitingObservational

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

NCT ID: NCT07335315Sponsor: Mayo ClinicLast updated: 2026-01-13

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.

Arms & interventions

Diagnostic TestContrast enhanced pituitary magnetic resonance imaging (MRI)
Pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound.
Diagnostic TestContrast 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 TestNon-Contrast Ultrasound
Intra-operative ultrasound without contrast for pituitary adenomas and MRI

Outcome measures

Primary

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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline

Eligibility criteria

Sex: AllAge: All agesHealthy volunteers: No

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)

Study locations (1)

Mayo Clinic

Rochester, Minnesota, 55905

Recruiting

Neurologic Surgery Research Department · Contact

507-293-7354