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临床试验/NCT02275871
NCT02275871终止不适用

Dual-energy Contrast-enhanced Digital Subtraction Mammography (CESM) as a Tool to Screen High Risk Women for Breast Cancer: a Comparison to Screening Breast MRI

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
44
试验地点
2
主要终点
Number of cancers and false positive findings identified on CESM versus MRI as a measure of sensitivity and specificity

研究概览

简要总结

This research study is comparing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) to MRI as a screening tool for breast cancer.

详细描述

This research study is being done to test how well a contrast enhanced mammogram compares to MRI in screening for breast cancer in people who are at higher risk for developing breast cancer.

Standard screening mammograms can miss breast cancers due to its inability to "see through" dense breast tissue. For this reason, women at increased risk for the development of breast cancer often undergo additional screening beyond conventional mammography with magnetic resonance imaging (MRI). Although screening MRI is very sensitive for finding breast cancer, it also finds many areas that are benign (not cancer). The only way to know which is the cancer is to perform a biopsy, which contributes to patient anxiety and leads to many unnecessary biopsies.

In the preliminary studies performed in women already diagnosed with breast cancer, contrast enhanced mammography was shown to have a similar sensitivity for finding primary breast cancer but detected fewer of the benign findings which would result in fewer unnecessary biopsies. It is also a faster and less expensive exam compared to MRI. Contrast mammography was FDA approved in 2011 and is used now as a tool to help work-up abnormalities seen on standard mammography and ultrasound.

We are now studying to see if contrast enhanced mammography will also be a beneficial tool in the screening setting to screen high risk patients for breast cancer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Age > or equal to 30 years
  • High risk (>20% lifetime risk)
  • Has a bilateral mammogram within the last 7 months
  • Has had a same day high risk screening MRI

排除标准

  • Participants who have a known allergy or contraindication to iodinated contrast.
  • Participants who have a known allergy to food or medications.
  • Participants who have renal insufficiency or failure.
  • Participants who are pregnant or breastfeeding.
  • Participants with a concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.

结局指标

主要结局

Number of cancers and false positive findings identified on CESM versus MRI as a measure of sensitivity and specificity

时间窗: 4 years

All CESM and MRI cases will be evaluated for the presence or absence of malignancy and will be coded to reflect this interpretation. Breast imaging-reporting and data system (BIRADS) scores of 1-3 represent the absence of malignancy and BIRADS code of 4-5 represent the presence of malignancy. These cases will be compared to the truth of whether malignancy developed in the patient based on biopsy results and long term clinical follow-up (2 years).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordana Phillips, MD

Principal Investigator

Beth Israel Deaconess Medical Center

研究点 (2)

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