Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMayo Clinic

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

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mayo Clinic

Lead sponsor

American Society of Head and Neck Radiology

Collaborator

GE Healthcare

Collaborator

Lantheus Medical Imaging

Collaborator