Actively Recruiting
Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of 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
132 weeks
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
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
Official 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 need for resection of non-corticotroph adenomas
- Agreement to undergo transsphenoidal pituitary surgery
- Patients undergoing any pituitary surgery with designated neurosurgeons
- Use of intra-operative BK ultrasound without contrast as part of procedure
You will not qualify if you...
- Unable to consent or legal guardian/representative declines consent
- Known or suspected hypersensitivity to microbubble contrast agents or components such as polyethylene glycol
- Women of child-bearing potential with positive pregnancy test prior to procedure
- Presence of right to left, bi-directional, or transient right to left cardiac shunts
- Hypersensitivity to perflutren
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
N
Neurologic Surgery Research Department
CONTACT
I
Ian Mark, MD
CONTACT
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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