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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07335315
Status
Recruiting
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Conditions

  • Cushing Disease
  • Pituitary Adenoma

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 19, 2024
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
110 participants (estimated)

Arms

  • Arm: Contrast
    Patients who are scheduled for transsphenoidal surgical resection for Cushing disease or transsphenoidal resection for non-corticotroph adenomas.
  • Arm: Non-Contrast
    Patients who are scheduled for a pituitary surgical procedure requiring an intra-operative ultrasound without contrast.

Primary Outcome Measure

Scoring of non-contrast ultrasound images [ Time Frame: Baseline ]

Central Contacts

  • Neurologic Surgery Research Department
    507-293-7354
    [email protected]
  • Ian Mark, MD
    507-284-3211

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Neurologic Surgery Research Department
507-293-7354

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