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NCT Number: NCT07335315

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

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.

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Key information

Conditions

Pituitary Adenoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cushing Disease Endocrine Gland Neoplasms Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pituitary ACTH Hypersecretion Pituitary Diseases Pituitary Neoplasms Supratentorial Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Neurologic Surgery Research Department

CONTACT

507-293-7354

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For Contrast Based Protocol:

Inclusion criteria

  • Diagnosis of Cushing disease or required resection for non-corticotroph adenomas
  • Agree to transsphenoidal resection.

Exclusion criteria

  • Patients who are unable to consent (or if their legal guardian/representative decline to consent)
  • Patients who have known or suspected hypersensitivity to microbubble contrast agents or its components such as polyethylene glycol (PEG).
  • Women of child-bearing potential with a positive pregnancy test prior to procedure.
  • Patients who have right to left, bi-directional, or transient right to left cardiac shunts.
  • Patients who have hypersensitivity to perflutren.

For Non-Contrast Based Protocol:

Inclusion criteria

  • Patients undergoing any pituitary surgery with the study designated neurosurgeons.
  • Patients whose procedures require the use of an intra-operative BK ultrasound without contrast.

Exclusion criteria

  • Patients who are unable to consent (or if their legal guardian/representative decline to consent)

Treatment and study plan

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

Primary outcomes

  1. Scoring of non-contrast ultrasound images

    Time frame: Baseline

    Non-contrast ultrasound images will be evaluated by a board certified neuroradiologists with experience reviewing pituitary imaging. The ultrasound images will be scored on the identification, size, location, echogenicity, and enhancement of any potential pituitary lesions as well as a confidence level in identifying the adenoma (1-5 Likert scale) with 1 being non-diagnostic/poor and 5 being excellent/diagnostic quality.

  2. Scoring of contrast-enhanced ultrasound images

    Time frame: Baseline

    Contrast-enhanced ultrasound images will be evaluated by a board certified neuroradiologists with experience reviewing pituitary imaging. The ultrasound images will be scored on the identification, size, location, echogenicity, and enhancement of any potential pituitary lesions as well as a confidence level in identifying the adenoma (1-5 Likert scale) with 1 being non-diagnostic/poor and 5 being excellent/diagnostic quality.

  3. Scoring of pituitary MRI images

    Time frame: Baseline

    Preoperative Research Pituitary MRI images will be evaluated by a board certified neuroradiologists with experience reviewing pituitary imaging. The MRI images will be scored on the identification, size, location, echogenicity, and enhancement of any potential pituitary lesions as well as a confidence level in identifying the adenoma (1-5 Likert scale) with 1 being non-diagnostic/poor and 5 being excellent/diagnostic quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Ian Mark, MD

CONTACT

507-284-3211 ext. 61206

Neurologic Surgery Research Department

CONTACT

[email protected]

507-293-7354

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • American Society of Head and Neck Radiology
  • GE Healthcare
  • Lantheus Medical Imaging

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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