RecruitingNCT07335315

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

Sponsor

Mayo Clinic

Enrollment

110 participants

Start Date

Jun 19, 2024

Study Type

OBSERVATIONAL

Conditions

Pituitary Adenoma Cushing Disease

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

Inclusion Criteria5

For Contrast Based Protocol:
Diagnosis of Cushing disease or required resection for non-corticotroph adenomas
Agree to transsphenoidal resection.
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 Criteria7

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:
• Patients who are unable to consent (or if their legal guardian/representative decline to consent)

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