Clinical trial · Observational
Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cushing Disease | — | UNRESOLVED | — |
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast enhanced pituitary magnetic resonance imaging (MRI) | Diagnostic Test | — | UNRESOLVED |
| Contrast enhanced ultrasound | Diagnostic Test | — | UNRESOLVED |
| Non-Contrast Ultrasound | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Contrast
- description
- Patients who are scheduled for transsphenoidal surgical resection for Cushing disease or transsphenoidal resection for non-corticotroph adenomas.
- interventionNames
- Diagnostic Test: Contrast enhanced pituitary magnetic resonance imaging (MRI)
- Diagnostic Test: Contrast enhanced ultrasound
- label
- Non-Contrast
- description
- Patients who are scheduled for a pituitary surgical procedure requiring an intra-operative ultrasound without contrast.
- interventionNames
- Diagnostic Test: Non-Contrast Ultrasound
Primary outcomes (3)
- measure
- Scoring of non-contrast ultrasound images
- timeFrame
- Baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available