Academic-Industrial Partnership for Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging
研究概览
简要总结
This is a 4-arm, single-center study involving 40 participants. Ten healthy volunteers will be enrolled for system imaging optimization, and thirty (30) patients with previously identified lesions in the breast, liver, or kidney-based on prior ultrasound or cross-sectional imaging-will be imaged. Recruitment will be conducted such that ten patients are included from each anatomic region.
The fourth arm will consist of 10 healthy volunteers who will be imaged to allow optimization of imaging parameters. Optimization is is required again due to the use of a different ultrasound system employing a new imaging technique. Parameters such as frame rate, power, depth of imaging, and linear translation rate will be adjusted during this process.
The primary objectives of the study are to assess the sensitivity and specificity of Contrast Enhanced Super-Resolution (CESR) imaging in evaluating known lesions in the breast, liver, and kidney. These results will be compared with pathological findings. The secondary objectives are to compare the sensitivity and specificity of CESR imaging with those of traditional B-mode ultrasound in differentiating malignant from benign lesions in these same organs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥18 years old
- •Patient had a diagnostic ultrasound study performed at University of North Carolina
- •Scheduled for a biopsy
- •Lesion visualized on ultrasound
- •Able to provide informed consent
- •Negative urine pregnancy test in women of child-bearing potential
排除标准
- •Institutionalized subject (prisoner or nursing home patient)
- •Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD)
- •Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
- •Active cardiac disease including any of the following
- •Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
- •Unstable angina.
- •Severe arrhythmia (i.e., ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes).
- •Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
- •Pulmonary hypertension
- •Cardiac shunts
研究组 & 干预措施
Arm 1: Healthy Volunteers
Participants without any disease diagnosis.
干预措施: contrast agent perflutren lipid (Drug)
Arm 1: Healthy Volunteers
Participants without any disease diagnosis.
干预措施: Ultrasound Imaging (Device)
Arm 2: Breast Imaging Patients
Participants are going to be assessed breast cancer.
干预措施: contrast agent perflutren lipid (Drug)
Arm 2: Breast Imaging Patients
Participants are going to be assessed breast cancer.
干预措施: Ultrasound Imaging (Device)
Arm 3: Kidney Imaging Patients
Participants are going to be assessed kidney cancer.
干预措施: contrast agent perflutren lipid (Drug)
Arm 3: Kidney Imaging Patients
Participants are going to be assessed kidney cancer.
干预措施: Ultrasound Imaging (Device)
Arm 4: Liver Imaging Patients
Participants are going to be assessed liver cancer.
干预措施: contrast agent perflutren lipid (Drug)
Arm 4: Liver Imaging Patients
Participants are going to be assessed liver cancer.
干预措施: Ultrasound Imaging (Device)
结局指标
主要结局
Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging
时间窗: Biopsy date (Up to 2 months)
Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging will be evaluated by comparing image analyses to the pathological results for these lesions. Sensitivity will be defined as the proportion of lesions detected by CESR to be positive among lesions confirmed as positive by pathological results.
Specificity of Contrast Enhanced Super-Resolution (CESR) breast imaging
时间窗: Biopsy date (Up to 2 months)
Specificity of Contrast Enhanced Super-Resolution (CESR) breast imaging will be evaluated by comparing image analyses to the pathological results for these lesions. Specificity will be defined as the proportion of lesions detected by CESR to be negative among lesions confirmed as negative by pathological results.
Sensitivity of Contrast Enhanced Super-Resolution (CESR) kidney imaging
时间窗: Biopsy date (Up to 2 months)
Sensitivity of Contrast Enhanced Super-Resolution (CESR) kidney imaging will be evaluated by comparing image analyses to the pathological results for these lesions. Sensitivity will be defined as the proportion of lesions detected by CESR to be positive among lesions confirmed as positive by pathological results.
Specificity of Contrast Enhanced Super-Resolution (CESR) kidney imaging
时间窗: Biopsy date (Up to 2 months)
Specificity of Contrast Enhanced Super-Resolution (CESR) kidney imaging will be evaluated by comparing image analyses to the pathological results for these lesions. Specificity will be defined as the proportion of lesions detected by CESR to be negative among lesions confirmed as negative by pathological results.
Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging
时间窗: Biopsy date (Up to 2 months)
Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging will be evaluated by comparing image analyses to the pathological results for these lesions. Sensitivity will be defined as the proportion of lesions detected by CESR to be positive among lesions confirmed as positive by pathological results.
Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging
时间窗: Biopsy date (Up to 2 months)
Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging will be evaluated by comparing image analyses to the pathological results for these lesions. Specificity will be defined as the proportion of lesions detected by CESR to be negative among lesions confirmed as negative by pathological results.
次要结局
- Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- breast(Biopsy date (Up to 2 months))
- Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- kidney(Biopsy date (Up to 2 months))
- Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- liver(Biopsy date (Up to 2 months))