Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Contrast enhanced pituitary magnetic resonance imaging (MRI), Contrast enhanced ultrasound, Non-Contrast Ultrasound.
- Who it may be relevant to
- Registry conditions: Pituitary Adenoma, Cushing Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Contrast enhanced pituitary magnetic resonance imaging (MRI)
Pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound. - Diagnostic test 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 - Diagnostic test Non-Contrast Ultrasound
Intra-operative ultrasound without contrast for pituitary adenomas and MRI
Primary outcome measures
- Scoring of non-contrast ultrasound images [Time frame: Baseline]
- Scoring of contrast-enhanced ultrasound images [Time frame: Baseline]
- Scoring of pituitary MRI images [Time frame: Baseline]
Eligibility criteria
For Contrast Based Protocol:
Inclusion criteria
- Diagnosis of Cushing disease or required resection for non-corticotroph adenomas
- Agree to transsphenoidal resection.
Exclusion criteria
- 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:
Inclusion criteria
- 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 are unable to consent (or if their legal guardian/representative decline to consent)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT07335315 · 23-009009