About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of Cushing disease or required resection for non-corticotroph adenomas
Agree to transsphenoidal resection.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Contrast enhanced pituitary magnetic resonance imaging (MRI)
- Contrast enhanced ultrasound
- Non-Contrast Ultrasound
Treatment groups
Sponsors and collaborators
Mayo Clinic
Lead sponsor
American Society of Head and Neck Radiology
Collaborator
GE Healthcare
Collaborator
Lantheus Medical Imaging
Collaborator