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

Mayo Clinic

Status: Enrolling

Conditions: Cushing Disease; Pituitary Adenoma

Treatments: Diagnostic Test: Contrast enhanced pituitary magnetic resonance imaging (MRI); Diagnostic Test: Non-Contrast Ultrasound; Diagnostic Test: Contrast enhanced ultrasound

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07335315

23-009009

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

110 participants in 2 patient groups

Contrast

Description:

Patients who are scheduled for transsphenoidal surgical resection for Cushing disease or transsphenoidal resection for non-corticotroph adenomas.

Treatment:

Diagnostic Test: Contrast enhanced ultrasound

Diagnostic Test: Contrast enhanced pituitary magnetic resonance imaging (MRI)

Non-Contrast

Description:

Patients who are scheduled for a pituitary surgical procedure requiring an intra-operative ultrasound without contrast.

Treatment:

Diagnostic Test: Non-Contrast Ultrasound