[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618722":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":63,"collaborators":66,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":10,"eligibilityCriteria":80,"healthyVolunteers":77,"sex":81,"minAge":10,"maxAge":10,"enrollmentInfo":82,"targetDuration":85,"studyType":86,"phases":10,"briefSummary":87,"conditions":88,"keywords":10,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Contrast",null,"Patients who are scheduled for transsphenoidal surgical resection for Cushing disease or transsphenoidal resection for non-corticotroph adenomas.",[13,14],"Diagnostic Test: Contrast enhanced pituitary magnetic resonance imaging (MRI)","Diagnostic Test: Contrast enhanced ultrasound",{"label":16,"type":10,"description":17,"interventionNames":18},"Non-Contrast","Patients who are scheduled for a pituitary surgical procedure requiring an intra-operative ultrasound without contrast.",[19],"Diagnostic Test: Non-Contrast Ultrasound",[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DIAGNOSTIC_TEST","Contrast enhanced pituitary magnetic resonance imaging (MRI)","Pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound.",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"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.\n\nA 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.",[9],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Non-Contrast Ultrasound","Intra-operative ultrasound without contrast for pituitary adenomas and MRI",[16],[35],{"name":36,"affiliation":5,"role":37},"Ian Mark, MD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},"Neurologic Surgery Research Department","CONTACT","507-293-7354","Riess.Lesley@mayo.edu",{"name":36,"role":41,"phone":45,"phoneExt":46,"email":10},"507-284-3211","61206",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-92.4699,44.02163,{"lat":59,"lon":58},[62],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":10},{"type":37,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ian T. Mark","Principal Investigator",[67,70,73],{"name":68,"class":69},"American Society of Head and Neck Radiology","UNKNOWN",{"name":71,"class":72},"GE Healthcare","INDUSTRY",{"name":74,"class":72},"Lantheus Medical Imaging","100618722","evaluation-of-intraoperative-contrast-enhanced-ultrasound-for-the-identification-of-pituitary-adenoma-in-cushings-disease-compared-to-other-pituitary-tumors-100618722",false,"NCT07335315","Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors","For Contrast Based Protocol:\n\nInclusion Criteria:\n\n* Diagnosis of Cushing disease or required resection for non-corticotroph adenomas\n* Agree to transsphenoidal resection.\n\nExclusion Criteria:\n\n* Patients who are unable to consent (or if their legal guardian\u002Frepresentative decline to consent)\n* Patients who have known or suspected hypersensitivity to microbubble contrast agents or its components such as polyethylene glycol (PEG).\n* Women of child-bearing potential with a positive pregnancy test prior to procedure.\n* Patients who have right to left, bi-directional, or transient right to left cardiac shunts.\n* Patients who have hypersensitivity to perflutren.\n\nFor Non-Contrast Based Protocol:\n\nInclusion Criteria:\n\n* Patients undergoing any pituitary surgery with the study designated neurosurgeons.\n* Patients whose procedures require the use of an intra-operative BK ultrasound without contrast.\n\nExclusion Criteria:\n\n• Patients who are unable to consent (or if their legal guardian\u002Frepresentative decline to consent)","ALL",{"count":83,"type":84},110,"ESTIMATED","6 Months","OBSERVATIONAL","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.",[89,90],"Pituitary Adenoma","Cushing Disease","2026-01-05",{"date":93,"type":94},"2026-01-13","ACTUAL",{"date":96,"type":94},"2024-06-19",{"date":98,"type":84},"2027-01",{"name":5,"class":6},1]