Recruiting

Ultrasound Imaging

Sponsor:

Mayo Clinic

Code:

NCT07335315

Conditions

Pituitary Adenoma

Cushing Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Contrast enhanced pituitary magnetic resonance imaging (MRI)

Contrast enhanced ultrasound

Non-Contrast Ultrasound

Study Details

Brief 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.

Conditions

Pituitary Adenoma

Cushing Disease

Study ID

NCT07335315

Start date

Jun 19, 2024

Status verified date

Jan, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

110 participants

Anticipated

Interventions and Outcome Measures

Arms

Contrast

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

Non-Contrast

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

Interventions

Contrast enhanced pituitary magnetic resonance imaging (MRI)

Pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound.

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.

Non-Contrast Ultrasound

Intra-operative ultrasound without contrast for pituitary adenomas and MRI

Primary outcome measure

  • Scoring of non-contrast ultrasound images [ Time Frame: Baseline ]
  • Scoring of contrast-enhanced ultrasound images [ Time Frame: Baseline ]
  • Scoring of pituitary MRI images [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Neurologic Surgery Research Department

507-293-7354Riess.Lesley@mayo.edu

Ian Mark, MD

507-284-3211

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Neurologic Surgery Research Department

507-293-7354

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-13.