Actively Recruiting
Evaluation of Intraoperative Contrast Enhanced Ultrasound for Identifying Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors
Led by Mayo Clinic · Updated on 2026-01-13
110
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
A
American Society of Head and Neck Radiology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new imaging technique using contrast enhanced ultrasound during surgery to better identify pituitary adenomas in patients with Cushing disease and other pituitary tumors. This first-in-humans pilot study aims to determine if this approach can help surgeons remove tumors more precisely while preserving normal pituitary tissue, potentially improving clinical outcomes. The study may lead to a larger, multi-center clinical trial if successful. Participants undergoing transsphenoidal pituitary surgery will be divided into two groups. One group will receive contrast enhanced intraoperative ultrasound imaging using Definity microbubbles administered intravenously, with imaging performed in transverse and sagittal planes. The other group will have intraoperative ultrasound without contrast. All participants will also have pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound performed as part of their evaluation. During the study, researchers will score and compare the quality of non-contrast ultrasound, contrast enhanced ultrasound, and MRI images to assess their ability to identify pituitary lesions. Participants will undergo standard surgical procedures with added imaging tests, and researchers will monitor imaging results to evaluate the diagnostic value of the contrast technique. The study is observational and will continue until January 2027.
CONDITIONS
Brief Title
Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Cushing disease or non-corticotroph pituitary adenoma requiring surgery
- Scheduled for transsphenoidal pituitary resection
- Agree to undergo transsphenoidal surgical resection
- Patients undergoing any pituitary surgery with designated neurosurgeons requiring intraoperative ultrasound without contrast
- Able to give informed consent
You will not qualify if you...
- Unable to consent or legal guardian declines consent
- Known or suspected allergy to microbubble contrast agents or components like polyethylene glycol (PEG)
- Women of child-bearing potential with positive pregnancy test before procedure
- Presence of right to left, bi-directional, or transient right to left cardiac shunts
- Known allergy to perflutren
- For non-contrast group, unable to consent or legal guardian declines consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility assessment
Duration - Day of surgery
Participants undergo pre-operative contrast enhanced pituitary MRI and intraoperative ultrasound imaging with or without contrast during their scheduled pituitary surgery.
1 surgical visit including imaging procedures
Duration - Up to several weeks post-surgery as per routine care
Participants are observed following surgery to assess outcomes and safety.
Approximately 1 to 2 post-operative visits
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
N
Neurologic Surgery Research Department
I
Ian Mark, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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