Pituitary Adenoma, Cushing Disease
Conditions
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.
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
Sponsors
American Society of Head and Neck Radiology
GE Healthcare
Lantheus Medical Imaging
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scoring of non-contrast ultrasound images | Baseline | 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. |
| Scoring of contrast-enhanced ultrasound images | Baseline | 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. |
| Scoring of pituitary MRI images | Baseline | 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. |
Countries
United States
Contacts
Primary ContactNeurologic Surgery Research Department
Backup ContactIan Mark, MD
Outcome results
None listed