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Observational Study of Contrast Enhanced Ultrasound for Pituitary Tumors

This study is looking at new ways to identify pituitary adenomas (non-cancerous growths on the pituitary gland) during surgery, especially for people with Cushing disease. Researchers are comparing how well standard MRI scans, regular ultrasound, and a special type of ultrasound called contrast enhanced ultrasound (using Definity microbubbles) can pinpoint these tumors. The goal is to see if this new ultrasound method can help surgeons remove only the tumor and leave healthy pituitary tissue untouched. You could be eligible if you have Cushing disease or another pituitary adenoma requiring surgery and agree to a transsphenoidal resection (a type of brain surgery). The study is currently unclear on its recruitment status.

Study design
This is an observational study planning to enroll 110 participants. It is a pilot and feasibility study, meaning it's an early look at this imaging approach.
What's involved
You would undergo pre-operative contrast enhanced pituitary MRI, and intraoperative ultrasound both with and without Definity microbubbles.
Compensation
Not stated in the trial record.
Follow-up
The study measures imaging scores at baseline, but no follow-up after treatment is specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07335315

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

Recruiting
Not specifiedAll AgesObservational
Mayo Clinic
~110 participants
Updated 2026-01-13 on ClinicalTrials.gov
What's tested:Contrast enhanced pituitary magnetic resonance imaging (MRI)Contrast enhanced ultrasoundNon-Contrast Ultrasound

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Scoring of non-contrast ultrasound images
Measured over Baseline
+2 more outcomes measured

Conditions

Pituitary Adenoma
Cushing Disease

Explore related trials

Cushing DiseasePituitary Neuroendocrine Tumor

NCT07335315

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic

    Rochester, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ian Mark, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Neurologic Surgery Research Department
[email protected]
507-293-7354
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Scoring of non-contrast ultrasound imagesBaseline

    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.

  • Scoring of contrast-enhanced ultrasound imagesBaseline

    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.

  • Scoring of pituitary MRI imagesBaseline

    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.