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

Purpose

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.

Conditions

Pituitary Adenoma
Cushing Disease

Eligibility

Eligible Ages: All ages
Eligible Sex: All
Accepts Healthy Volunteers: No

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 Design

Phase
Study Type: Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
Contrast	Patients who are scheduled for transsphenoidal surgical resection for Cushing disease or transsphenoidal resection for non-corticotroph adenomas.	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
Non-Contrast	Patients who are scheduled for a pituitary surgical procedure requiring an intra-operative ultrasound without contrast.	Diagnostic Test: Non-Contrast Ultrasound Intra-operative ultrasound without contrast for pituitary adenomas and MRI

Recruiting Locations

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905

Contact:
Neurologic Surgery Research Department
507-293-7354

More Details

NCT ID: NCT07335315
Status: Recruiting
Sponsor: Mayo Clinic

Study Contact

Neurologic Surgery Research Department
507-293-7354
Riess.Lesley@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.