Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors
1 other identifier
observational
110
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2024
CompletedFirst Submitted
Initial submission to the registry
January 5, 2026
CompletedFirst Posted
Study publicly available on registry
January 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
January 13, 2026
January 1, 2026
2.5 years
January 5, 2026
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Scoring of non-contrast ultrasound images
Non-contrast ultrasound images will be evaluated by a board certified neuroradiologists with experience reviewing pituitary imaging. The ultrasound images will be scored on the identification, size, location, echogenicity, and enhancement of any potential pituitary lesions as well as a confidence level in identifying the adenoma (1-5 Likert scale) with 1 being non-diagnostic/poor and 5 being excellent/diagnostic quality.
Baseline
Scoring of contrast-enhanced ultrasound images
Contrast-enhanced ultrasound images will be evaluated by a board certified neuroradiologists with experience reviewing pituitary imaging. The ultrasound images will be scored on the identification, size, location, echogenicity, and enhancement of any potential pituitary lesions as well as a confidence level in identifying the adenoma (1-5 Likert scale) with 1 being non-diagnostic/poor and 5 being excellent/diagnostic quality.
Baseline
Scoring of pituitary MRI images
Preoperative Research Pituitary MRI images will be evaluated by a board certified neuroradiologists with experience reviewing pituitary imaging. The MRI images will be scored on the identification, size, location, echogenicity, and enhancement of any potential pituitary lesions as well as a confidence level in identifying the adenoma (1-5 Likert scale) with 1 being non-diagnostic/poor and 5 being excellent/diagnostic quality.
Baseline
Study Arms (2)
Contrast
Patients who are scheduled for transsphenoidal surgical resection for Cushing disease or transsphenoidal resection for non-corticotroph adenomas.
Non-Contrast
Patients who are scheduled for a pituitary surgical procedure requiring an intra-operative ultrasound without contrast.
Interventions
Pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound.
Intra-operative ultrasound without contrast for pituitary adenomas and MRI
Contrast enhanced intraoperative ultrasound imaging with Definity microbubbles that will be activated per the manufacturer specification and administered as a bolus of 0.2 mL of perflutren lipid microsphere intravenously followed by a 10 mL flush of saline. The pituitary will be imaged in the transverse plane for 2 minutes following this bolus. A repeat injection of the same ultrasound contrast dose and saline flush will be performed, and the pituitary will be imaged in the sagittal plane for 2 minutes.
Eligibility Criteria
Patients with a pituitary adenoma or lesion that will undergo transnasal surgery
You may qualify if:
- Diagnosis of Cushing disease or required resection for non-corticotroph adenomas
- Agree to transsphenoidal resection.
You may not qualify if:
- 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:
- Patients undergoing any pituitary surgery with the study designated neurosurgeons.
- Patients whose procedures require the use of an intra-operative BK ultrasound without contrast.
- Patients who are unable to consent (or if their legal guardian/representative decline to consent)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American Society of Head and Neck Radiologycollaborator
- Mayo Cliniclead
- GE Healthcarecollaborator
- Lantheus Medical Imagingcollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian Mark, MD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 5, 2026
First Posted
January 13, 2026
Study Start
June 19, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share