[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618722":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":62,"collaborators":65,"id":74,"slug":10,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":10,"eligibilityCriteria":78,"healthyVolunteers":75,"sex":79,"minAge":10,"maxAge":10,"enrollmentInfo":80,"targetDuration":83,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":10,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"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,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Rochester","Minnesota","55905","United States",{"type":55,"coordinates":56},"Point",[57,58],-92.4699,44.02163,{"lat":58,"lon":57},[61],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":10},{"type":37,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ian T. Mark","Principal Investigator",[66,69,72],{"name":67,"class":68},"American Society of Head and Neck Radiology","UNKNOWN",{"name":70,"class":71},"GE Healthcare","INDUSTRY",{"name":73,"class":71},"Lantheus Medical Imaging","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":81,"type":82},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.",[87,88],"Pituitary Adenoma","Cushing Disease","2026-01-05",{"date":91,"type":92},"2026-01-13","ACTUAL",{"date":94,"type":92},"2024-06-19",{"date":96,"type":82},"2027-01",{"name":5,"class":6},1]