Pituitary AdenomaNCT07335315
Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors
An observational study of Pituitary Adenoma and Cushing Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pituitary Adenoma, Cushing Disease
- What is being tested?
- Contrast enhanced pituitary magnetic resonance imaging (MRI), Contrast enhanced ultrasound and Non-Contrast Ultrasound
- Type of treatment
- Injection or infusion
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2024to Jan 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a pituitary adenoma or lesion that will undergo transnasal surgery
Who may be able to join
- 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.
Who cannot join
- 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:
- Patients who are unable to consent (or if their legal guardian/representative decline to consent)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ian Mark, MD contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Neurologic Surgery Research Department, 507-293-7354
About this study
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
- Being tested
- Contrast enhanced pituitary magnetic resonance imaging (MRI), Contrast enhanced ultrasound, Non-Contrast Ultrasound
- Medical subject headings
- Pituitary Neoplasms, Pituitary ACTH Hypersecretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast enhanced pituitary magnetic resonance imaging (MRI)Diagnostic test
Pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound.
Contrast enhanced ultrasoundDiagnostic 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 UltrasoundDiagnostic test
Intra-operative ultrasound without contrast for pituitary adenomas and MRI
| Study group | Role | What they receive |
|---|---|---|
| Contrast | Patients who are scheduled for transsphenoidal surgical resection for Cushing disease or transsphenoidal resection for non-corticotroph adenomas. Receives: Diagnostic Test: Contrast enhanced pituitary magnetic resonance imaging (MRI); Diagnostic Test: Contrast enhanced ultrasound | |
| Non-Contrast | Patients who are scheduled for a pituitary surgical procedure requiring an intra-operative ultrasound without contrast. Receives: Diagnostic Test: Non-Contrast Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoring of non-contrast ultrasound images
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.
Measured: Baseline
Scoring of contrast-enhanced ultrasound images
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.
Measured: Baseline
Scoring of pituitary MRI images
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start19 Jun 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Head and Neck Radiology, GE Healthcare, Lantheus Medical Imaging
- Responsible party
- Principal investigator, Ian T. Mark, Mayo Clinic
- Investigators
- Ian Mark, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335315
- Sponsor's protocol ID
- 23-009009
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors
- ClinicalTrials.gov ID
- NCT07335315
- Acronym / sponsor ID
- 23-009009
- Conditions
- Pituitary Adenoma, Cushing Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- American Society of Head and Neck Radiology, GE Healthcare, Lantheus Medical Imaging
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contrast | – | Diagnostic Test: Contrast enhanced pituitary magnetic resonance imaging (MRI), Diagnostic Test: Contrast enhanced ultrasoundPatients who are scheduled for transsphenoidal surgical resection for Cushing disease or transsphenoidal resection for non-corticotroph adenomas. |
| Non-Contrast | – | Diagnostic Test: Non-Contrast UltrasoundPatients who are scheduled for a pituitary surgical procedure requiring an intra-operative ultrasound without contrast. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a pituitary adenoma or lesion that will undergo transnasal surgery
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast enhanced pituitary magnetic resonance imaging (MRI)Pre-operative contrast enhanced pituitary MRI and non-contrast intraoperative ultrasound. | Diagnostic test | Contrast |
| Contrast enhanced ultrasoundContrast 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 | Contrast |
| Non-Contrast UltrasoundIntra-operative ultrasound without contrast for pituitary adenomas and MRI | Diagnostic test | Non-Contrast |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ian Mark, MD contact
Ian Mark, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Adenoma and Cushing Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neurologic Surgery Research Department (507-293-7354, Riess.Lesley@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoring of non-contrast ultrasound images (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.