Intraoperative contrast-enhanced ultrasound to locate pituitary adenomas in Cushing's disease

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

This pilot tests whether using contrast-enhanced ultrasound during transsphenoidal surgery helps surgeons find and remove pituitary adenomas in people with Cushing's disease.

Quick facts

• Study type: Observational
• Enrollment: 110 (estimated)
• Sex: All
• Sponsor: Mayo Clinic (other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT07335315 on ClinicalTrials.gov

What this trial studies

This first-in-humans pilot combines an endonasal ultrasound transducer array with contrast-enhanced ultrasound (CEUS) to provide real-time, intraoperative imaging of pituitary lesions during transsphenoidal surgery. The protocol includes contrast and non-contrast ultrasound arms and incorporates contrast-enhanced pituitary MRI for preoperative localization. The goal is lesion-specific image guidance that can help surgeons distinguish adenoma from normal pituitary tissue and guide resection. Data collected will focus on feasibility, imaging characteristics, and whether CEUS changes intraoperative decision-making to preserve normal gland.

Who should consider this trial

Good fit: Adults scheduled for transsphenoidal resection for Cushing's disease or other pituitary adenomas who can consent and do not have contraindications to microbubble contrast are ideal candidates.

Not a fit: Patients who are pregnant, have known hypersensitivity to microbubble contrast or perflutren, have relevant cardiac shunts, or who are not undergoing transsphenoidal surgery are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve tumor localization during surgery and reduce removal of normal pituitary tissue, lowering the risk of postoperative hypopituitarism.

How similar studies have performed: Contrast-enhanced ultrasound has demonstrated utility in other intraoperative and imaging settings, but using CEUS with an endonasal transducer for pituitary adenoma localization is novel and unproven in humans.

Eligibility 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)

Where this trial is running

Rochester, Minnesota

• Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: Ian Mark, MD — Mayo Clinic
• Study coordinator: Neurologic Surgery Research Department

Conditions: Pituitary Adenoma, Cushing Disease