Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors
NCT ID: NCT07335315
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
110 participants
OBSERVATIONAL
2024-06-19
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Contrast
Patients who are scheduled for transsphenoidal surgical resection for Cushing disease or transsphenoidal resection for non-corticotroph adenomas.
Contrast enhanced pituitary magnetic resonance imaging (MRI)
Pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound.
Contrast enhanced ultrasound
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.
Non-Contrast
Patients who are scheduled for a pituitary surgical procedure requiring an intra-operative ultrasound without contrast.
Non-Contrast Ultrasound
Intra-operative ultrasound without contrast for pituitary adenomas and MRI
Interventions
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Contrast enhanced pituitary magnetic resonance imaging (MRI)
Pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound.
Contrast enhanced ultrasound
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.
Non-Contrast Ultrasound
Intra-operative ultrasound without contrast for pituitary adenomas and MRI
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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 who are unable to consent (or if their legal guardian/representative decline to consent)
ALL
No
Sponsors
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American Society of Head and Neck Radiology
UNKNOWN
GE Healthcare
INDUSTRY
Lantheus Medical Imaging
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Ian T. Mark
Principal Investigator
Principal Investigators
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Ian Mark, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Ian Mark, MD
Role: CONTACT
Facility Contacts
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Neurologic Surgery Research Department
Role: primary
Other Identifiers
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23-009009
Identifier Type: -
Identifier Source: org_study_id
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