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| Name | Class |
|---|---|
| American Society of Head and Neck Radiology | UNKNOWN |
| GE Healthcare | INDUSTRY |
| Lantheus Medical Imaging | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast enhanced pituitary magnetic resonance imaging (MRI) | Diagnostic Test | Pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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For Contrast Based Protocol:
Inclusion Criteria:
Exclusion Criteria:
For Non-Contrast Based Protocol:
Inclusion Criteria:
Exclusion Criteria:
• Patients who are unable to consent (or if their legal guardian/representative decline to consent)
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Patients with a pituitary adenoma or lesion that will undergo transnasal surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neurologic Surgery Research Department | Contact | 507-293-7354 | Riess.Lesley@mayo.edu | |
| Ian Mark, MD | Contact | 507-284-3211 | 61206 |
| Name | Affiliation | Role |
|---|---|---|
| Ian Mark, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Contrast enhanced ultrasound | Diagnostic Test | 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 | Diagnostic Test | Intra-operative ultrasound without contrast for pituitary adenomas and MRI |
|
| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| D047748 | Pituitary ACTH Hypersecretion |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
| D015173 | Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D006964 | Hyperpituitarism |
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