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NCT07335315Recruiting

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

Source: ClinicalTrials.gov · Last updated 13 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
110 (estimated)
First submitted
5 Jan 2026
Start date
19 Jun 2024
Primary completion date
Jan 2027
Lead sponsor
Mayo Clinic
NCT number
NCT07335315

What you commit to

  • Study type: Observational
  • Planned participants: 110
  • From 19 Jun 2024 to the primary completion date, Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Women of child-bearing potential with a positive pregnancy test prior to procedure.

Other illness

  • Patients who have known or suspected hypersensitivity to microbubble contrast agents or its components such as polyethylene glycol (PEG).
  • 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:

Other

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

Who the study is looking for

  • 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.

Criteria the registry did not label

  • For Contrast Based Protocol:

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.