RecruitingNCT07335315

Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors


Sponsor

Mayo Clinic

Enrollment

110 participants

Start Date

Jun 19, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a special intraoperative ultrasound technique (contrast-enhanced ultrasound) can help surgeons better identify and locate pituitary tumors during brain surgery for Cushing's disease, compared to other pituitary tumors. **You may be eligible if...** - You have been diagnosed with Cushing's disease (caused by a pituitary tumor producing excess cortisol) OR you need surgery for another pituitary tumor - You have agreed to undergo transsphenoidal surgery (through the nose to reach the pituitary gland) - Alternatively, you are undergoing any pituitary surgery with the designated study surgeons (for the non-contrast protocol) **You may NOT be eligible if...** - You are unable to give consent (or your legal guardian declines) - You are allergic to the contrast agent used (or its ingredients, such as polyethylene glycol or perflutren) - You are pregnant - You have a heart condition with abnormal blood flow direction (right-to-left or bidirectional cardiac shunt) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTContrast enhanced pituitary magnetic resonance imaging (MRI)

Pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound.

DIAGNOSTIC_TESTContrast 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.

DIAGNOSTIC_TESTNon-Contrast Ultrasound

Intra-operative ultrasound without contrast for pituitary adenomas and MRI


Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT07335315


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