Evaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Scoring of non-contrast ultrasound images
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Contrast Based Protocol:
- •Inclusion Criteria:
- •Diagnosis of Cushing disease or required resection for non-corticotroph adenomas
- •Agree to transsphenoidal resection.
排除标准
- •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)
研究组 & 干预措施
Contrast
Patients who are scheduled for transsphenoidal surgical resection for Cushing disease or transsphenoidal resection for non-corticotroph adenomas.
干预措施: Contrast enhanced pituitary magnetic resonance imaging (MRI) (Diagnostic Test)
Contrast
Patients who are scheduled for transsphenoidal surgical resection for Cushing disease or transsphenoidal resection for non-corticotroph adenomas.
干预措施: Contrast enhanced ultrasound (Diagnostic Test)
Non-Contrast
Patients who are scheduled for a pituitary surgical procedure requiring an intra-operative ultrasound without contrast.
干预措施: Non-Contrast Ultrasound (Diagnostic Test)
结局指标
主要结局
Scoring of non-contrast ultrasound images
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点