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Ultrasound with contrast during surgery to find pituitary tumors in Cushing's disease

Tests contrast ultrasound during surgery to locate pituitary tumors, including in Cushing's disease.

Key facts

Who runs it
Mayo Clinic
Where
Rochester, United StatesSee the site
Trial code
Registry title
Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors
Status
Recruiting
People taking part
110 people, planned
Started
19 Jun 2024
Expected to end
Jan 2027
Type of study
Observational, 2 groups
Treatments tested
  • Contrast enhanced pituitary magnetic resonance imaging (MRI)
  • Contrast enhanced ultrasound
  • Non-Contrast Ultrasound
Record updated
13 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people having pituitary surgery. One group has Cushing disease or a non-corticotroph pituitary tumour and agrees to surgery through the nose. The other group has any pituitary surgery with an ultrasound probe used.

Sex
All sexes can join.
Disease stage
Cushing disease, or a pituitary tumour that is not corticotroph (contrast group). Any pituitary surgery with the study neurosurgeons (non-contrast group).

Main reasons for not taking part

  • Cannot give consent (or the legal guardian or representative declines)
  • Known or suspected allergy to microbubble contrast agents, such as polyethylene glycol (PEG), or to perflutren
  • Women who could have children and have a positive pregnancy test before the procedure
  • Heart shunts: right to left, bi-directional, or transient right to left

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • Diagnosis of Cushing disease or required resection for non-corticotroph adenomas
  • Agree to transsphenoidal resection
  • Patients undergoing any pituitary surgery with the study designated neurosurgeons
  • Patients whose procedures require the use of an intra-operative BK ultrasound without contrast

Who cannot take part

  • Women of child-bearing potential with a positive pregnancy test prior to procedure
  • Patients who have known or suspected hypersensitivity to microbubble contrast agents or its components such as polyethylene glycol (PEG)
  • 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:
  • Patients who are unable to consent (or if their legal guardian/representative decline to consent)
  • Patients who are unable to consent (or if their legal guardian/representative decline to consent)

Other criteria

  • For Contrast Based Protocol:

Where in United States

  • Mayo ClinicRochester, United StatesContact: Neurologic Surgery Research DepartmentTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Contrast

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

    Treatment: Contrast enhanced pituitary magnetic resonance imaging (MRI) and Contrast enhanced ultrasound

  • Non-Contrast

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

    Treatment: Non-Contrast Ultrasound

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors
Plain-language title
Ultrasound with contrast during surgery to find pituitary tumors in Cushing's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
13 January 2026