High Frame Rate 3-D Super Resolution Ultrasound Microvascular Imaging
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Sensitivity of Acoustic Angiography; Breast Imaging
研究概览
简要总结
This is a 3-arm single center study of 45 patients. These cohorts will include 15 breast patients scheduled to undergo a biopsy, and 15 thyroid patients scheduled to undergo fine needle aspiration, biopsy, or thyroidectomy that consent to undergo an acoustic angiography in conjunction with b-mode ultrasound prior to their scheduled biopsy. Prior to imaging clinical patients, the third arm will include 15 healthy volunteers that will be imaged to optimize imaging parameters.
详细描述
Increasing the sensitivity and specificity of diagnostic imaging in patients at high risk for breast or thyroid cancer could provide substantial clinical benefit by improving diagnosis, preventing over-treatment, and reducing healthcare costs. Acoustic angiography is a new type of contrast enhanced ultrasound imaging which is specifically sensitive to microvascular structure and density. It evaluates tumor micro-vasculature and may provide a powerful prognostic tool for the diagnosis of breast cancer, and eventually for treatment evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Breast Imaging Cohort
A total of 15 women with known breast lesions that are already scheduled to undergo a clinical biopsy
干预措施: Definity (Drug)
Breast Imaging Cohort
A total of 15 women with known breast lesions that are already scheduled to undergo a clinical biopsy
干预措施: Acoustic Angiography (Device)
Thyroid Imaging Cohort
A total of 15 participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy
干预措施: Definity (Drug)
Thyroid Imaging Cohort
A total of 15 participants with known thyroid lesions that are already scheduled to undergo a clinical biopsy
干预措施: Acoustic Angiography (Device)
Healthy Volunteers Cohort
A total of 15 participants will be included to optimize imaging parameters.
干预措施: Definity (Drug)
Healthy Volunteers Cohort
A total of 15 participants will be included to optimize imaging parameters.
干预措施: Acoustic Angiography (Device)
结局指标
主要结局
Sensitivity of Acoustic Angiography; Breast Imaging
时间窗: Baseline
The sensitivity of Acoustic Angiography in the analysis of known breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions. Sensitivity (%) = True Positives (TP)+False Negatives (FN)True Positives (TP)
Specificity of Acoustic Angiography; Breast Imaging (Percent of Negative Scans)
时间窗: Baseline
Specificity of Acoustic Angiography in the analysis of known breast lesions will be evaluated by comparing image analyses to the pathological results for these lesions. Specificity was calculated based on the formula, which is true negative / (true negative + false positive).
Sensitivity of Acoustic Angiography; Thyroid Imaging (Percent of Positive Scans)
时间窗: Baseline
Sensitivity of Acoustic Angiography in the analysis of know thyroid lesions will be evaluated by comparing image analyses to the pathological results for these lesions. The study closed early due to insufficient funding and did not reach target enrollment. No participants were enrolled in Arm 2 (Thyroid Imaging); therefore, no outcome measure results are available.
Specificity of Acoustic Angiography; Thyroid Imaging (Percent of Negative Scans)
时间窗: Baseline
Specificity of Acoustic Angiography in the analysis of known thyroid lesions will be evaluated by comparing image analyses to the pathological results for these lesions. The study closed early due to insufficient funding and did not reach target enrollment. No participants were enrolled in Arm 2 (Thyroid Imaging); therefore, no outcome measure results are available.
次要结局
- Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units)(Baseline)
- Specificity of Acoustic Angiography Compared to Conventional Ultrasound: Breast (Arbitrary Units)(Baseline)
- Sensitivity of Acoustic Angiography Compared to Conventional Ultrasound: Thyroid (Arbitrary Units)(Baseline)
- Area Under the Curve of Acoustic Angiography (Arbitrary Units)(Baseline)
- Radiologist Preference (Arbitrary Units)(Baseline)
- Specificity of Acoustic Angiography Compared to Conventional Ultrasound: Thyroid (Arbitrary Units)(Calculated once all imaging is complete [Anticipated 1.5 years])