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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Ian Mark, MD — Mayo Clinic
• Study coordinator: Neurologic Surgery Research Department
• Email: Riess.Lesley@mayo.edu
• Phone: 507-293-7354

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.