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

NCT07335315 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2026-01-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • American Society of Head and Neck Radiology

    collaborator UNKNOWN

  • GE Healthcare

    collaborator INDUSTRY

  • Lantheus Medical Imaging

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Ian Mark, MD · Mayo Clinic

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-19
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07335315 on ClinicalTrials.gov