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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Diagnosis of Cushing disease or required resection for non-corticotroph adenomas

• Agree to transsphenoidal resection.

• Patients undergoing any pituitary surgery with the study designated neurosurgeons.

• Patients whose procedures require the use of an intra-operative BK ultrasound without contrast.

Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Contact Information
Primary
Neurologic Surgery Research Department
Riess.Lesley@mayo.edu
507-293-7354
Backup
Ian Mark, MD
507-284-3211
Time Frame
Start Date: 2024-06-19
Estimated Completion Date: 2027-01
Participants
Target number of participants: 110
Treatments
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.
Sponsors
Leads: Mayo Clinic
Collaborators: GE Healthcare, Lantheus Medical Imaging, American Society of Head and Neck Radiology

This content was sourced from clinicaltrials.gov