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

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

Age range

Not specified

Sex

All

Healthy volunteers

No

Interventions

• 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

Location