Feasibility of Automated Breast Ultrasound (ABUS) Versus Handheld Ultrasound (HHUS) for Breast Cancer Surveillance in Women With Nipple Sparing or Skin Sparing Mastectomy With Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Detection of the residual tissue (i.e., artifact) in reconstructed nipple sparing mastectomy (NSM) and skin sparing mastectomy (SSM) patients by automated breast ultrasound (ABUS) and handheld ultrasound (HHUS)
研究概览
简要总结
This clinical trial evaluates automated breast ultrasound (ABUS) and handheld ultrasound (HHUS) for the screening of women who have undergone breast reconstruction after breast cancer. Ultrasounds use high-frequency sound waves to create pictures of internal organs and tissues. ABUS has been found to be equal to HHUS for whole breast screening, but no data exist on its use for screening of reconstructed patients. This clinical trial evaluates the feasibility of using ABUS versus HHUS to screen women who have undergone reconstruction.
详细描述
PRIMARY OBJECTIVE:
I. To show that ABUS reduces artifact compared to HHUS in terms of detection of the residual tissue in reconstructed nipple sparing mastectomy (NSM) and skin sparing mastectomy (SSM) patients.
SECONDARY OBJECTIVES:
I. To evaluate both the performance and interpretation times for ABUS and HHUS so that these factors can be considered when scheduling patients and for ease of implementation into practice.
II. A short survey will be administered immediately after both ultrasounds performed to enrolled patients to assess their experience with HHUS and ABUS, specifically addressing their perceived comfort level on a numerical scale and if they would be interested in obtaining subsequent annual screening HHUS or ABUS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>= 18 years of age at time of consent
- •Free of focal breast symptoms and with no suspicious breast physical exam findings
- •Previous unilateral NSM or SSM with implant (silicone, saline) or flap reconstruction performed at Thomas Jefferson University Hospital
- •Must be able to understand and provide signed and dated informed consent form. If a patient understands the informed consent but is unable to sign, a legally authorized representative (LAR) may sign
- •Willing to comply with all study procedures and be available for the duration of the study
- •Willing to honor any bills that may be incurred if the insurance company does not pay for the billed bilateral hand held ultrasound
排除标准
- •History of breast cancer recurrence
- •Current focal breast symptoms since NSM or SSM with reconstruction
- •NSM or SSM with reconstruction was performed years prior to study enrollment
- •Bilateral NSM or SSM with reconstruction
- •Females who are pregnant
研究组 & 干预措施
Screening (automated breast ultrasound, handheld ultrasound)
Participants undergo HHUS and ABUS in no required order over 1 hour.
干预措施: Ultrasonography (Procedure)
Screening (automated breast ultrasound, handheld ultrasound)
Participants undergo HHUS and ABUS in no required order over 1 hour.
干预措施: Automated Breast Ultrasound (Procedure)
结局指标
主要结局
Detection of the residual tissue (i.e., artifact) in reconstructed nipple sparing mastectomy (NSM) and skin sparing mastectomy (SSM) patients by automated breast ultrasound (ABUS) and handheld ultrasound (HHUS)
时间窗: Up to 1 year
This is a binary endpoint. The rate of artifact will be compared between handheld and automated scanning using McNemar test.
次要结局
未报告次要终点