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临床试验/NCT04841252
NCT04841252已完成不适用

Classification of Breast Masses Based on Visco-elastic Properties Using SAVE Method

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2012年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
266
试验地点
1
主要终点
Determine the efficacy of the SAVE method by correlating its results with pathology in a pathology in a population of patients with suspicious breast masses.

研究概览

简要总结

The purpose of this research is to conduct a clinical study to evaluate the efficacy of a noninvasive and quantitative tool for classification/diagnosis of breast masses. The main objective of this proposal is to test the SAVE (Sub-Hertz Analysis of Visco-Elasticity) method on a patient population of sufficient size to determine the sensitivity and specificity for malignant-benign discrimination of breast masses.

详细描述

Subject will sit or lie back on an examination bed. The investigators will use an ultrasound scanner to collect sonographic imaging data from the breast. For this purpose the investigators may use a clinical scanner such as Supersonics Aixplorer or similar or a research ultrasound machine such as Verasonics (this machine has been use in other Mayo IRB approved protocols such as IRB 11-001953). The ultrasound probe will be placed on the breast to visualize the mass. The probe will be pressed with a constant force for a period of 10-40 seconds. During this time ultrasound data will be recorded by the ultrasound scanner.

To keep the probe pressed on the breast with a constant force, the user may hold the probe by hand and press it steadily against the breast at constant force. This force is only a few Newtons (approximately half a Kg weight) which should be quite tolerable for a typical patient. Alternatively, the investigators may use an automated "actuator" to hold the probe steady and press it against the breast at a constant force to the same level. The reason for pressing the breast is to determine how the breast tissue gradually deforms; therefore this method to some extent simulates breast palpation.

The time needed to scan a subject for this study is short (a few minutes to set up, and about 10-40 seconds to scan). It will take approximately 20 minutes to complete the study. The scan can be done at the time of clinical breast sonography. The subject may be asked to hold her breath during the scan time if possible.

The investigators call this method "Sub-Hertz Analysis of Visco-Elasticity (SAVE)".

To facilitate subject access and shorten patient participation time, the investigator may station our system in the Breast Imaging area where routine clinical imaging procedures are performed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Females in age range between 18 and up who have a breast lesion that may or may not be suspicious for breast cancer, and are referred for Radiological investigation.

排除标准

  • No history of mastectomy or implants, or having any condition that does not allow proper use of our imaging devices.
  • Only include patients with masses detectable under ultrasound.

结局指标

主要结局

Determine the efficacy of the SAVE method by correlating its results with pathology in a pathology in a population of patients with suspicious breast masses.

时间窗: Before biopsy or at least 2 weeks post biopsy

Assessed using a two-phase design. The first phase will be the development aspects to determine a candidate threshold for T1 that produces Optimal diagnostic accuracy as quantified by the largest diagnostic odds ratio. The second phase of the study will be to apply this candidate threshold to the validation sample enrolled as a part of the specific aim to ensure diagnostic utility. For both phases of the analysis, overall diagnostic accuracy will be quantified by the area under the receiver operating characteristics (ROC) curve.

Determine the efficacy of SAVE method in classifying non-specific masses in a group of breast patients on the follow-up list.

时间窗: Before biopsy or at least 2 weeks post biopsy

The threshold determined in Aim 1 will be applied to the patients in this sample to calculate the diagnostic performance

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Azra Alizad

Principal Investigator

Mayo Clinic

研究点 (1)

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