NCT07335315

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pituitary Adenoma
• Cushing Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Contrast enhanced pituitary magnetic resonance imaging (MRI)	Pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound.
DIAGNOSTIC_TEST	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. A 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.
DIAGNOSTIC_TEST	Non-Contrast Ultrasound	Intra-operative ultrasound without contrast for pituitary adenomas and MRI

Timeline

• Start date: 2024-06-19
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study