Added Value of Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion to a Tertiary Cancer Center
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Accuracy of CEM for Incremental Cancer Detection in the Ipsilateral and Contralateral Breasts.
研究概览
简要总结
This clinical trial investigates contrast-enhanced mammography (CEM) in detecting breast cancer. CEM is similar to standard mammography, but it includes an injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. Diagnostic procedures, such as CEM, may increase the chance of finding breast cancers and decrease the risk of having unnecessary biopsies.
详细描述
PRIMARY OBJECTIVE:
I. To compare the accuracy of CEM and low energy (LE) images (equivalent of full field digital mammogram [FFDM] as the standard of care) for the detection of additional cancer sites in the affected breast and in the contralateral breast.
SECONDARY OBJECTIVES:
I. To evaluate the sensitivity, specificity, positive and negative predictive value of CEM compared to LE CEM images (FFDM equivalent), digital breast tomosynthesis (DBT) and ultrasound for the detection of additional malignant lesions in the ipsilateral and contralateral breast.
II. To evaluate the difference of the index cancer size estimation among CEM, LE images, DBT, and ultrasound compared to pathology measurements as the ground truth.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients 18 years of age or older with known invasive or in-situ breast cancer (BC) diagnosed at an outside facility and presenting to MD Anderson for staging with imaging
- •Female patients 18 years of age or older referred from outside institutions with imaging findings categorized as highly suspicious (Breast Imaging Reporting and Data System [BI-RADS] 5 or 4C) on outside imaging or on rereview by MD Anderson's radiologists and referred for staging at MD Anderson Cancer Center (MDACC)
- •Willingness to participate in the study and ability to provide informed consent
排除标准
- •Breast surgery within 6 months
- •Known allergy to iodine-containing contrast agents
- •History of anaphylactic reaction to any substance that required hospitalization or IV placement
- •Renal insufficiency; hyperthyroidism
- •Detection of non-breast primary or metastatic cancer in the breast
研究组 & 干预措施
Diagnostic (CEM, DBT, medical record)
Patient receive iodinated contrast agent IV and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed.
干预措施: Contrast-Enhanced Mammography (Procedure)
Diagnostic (CEM, DBT, medical record)
Patient receive iodinated contrast agent IV and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed.
干预措施: Digital Tomosynthesis Mammography (Procedure)
Diagnostic (CEM, DBT, medical record)
Patient receive iodinated contrast agent IV and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed.
干预措施: Electronic Health Record Review (Other)
Diagnostic (CEM, DBT, medical record)
Patient receive iodinated contrast agent IV and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed.
干预措施: Iodinated Contrast Agent (Drug)
结局指标
主要结局
Accuracy of CEM for Incremental Cancer Detection in the Ipsilateral and Contralateral Breasts.
时间窗: One timepoint (at presentation) for lesion characterization with 24 month follow-up for outcome data collection
Rate of malignancy in lesions de-novo detected on CEM at MDACC and not detected on outside facility imaging. New non-index lesions detected on CEM that had a benign/malignant outcome on image-guided biopsy, surgery, or had a 24-month imaging follow-up with no cancer development (lesion-level evaluation) \*Index lesion was defined as follows: A) Known cancer detected at an outside facility B) Highly suspicious imaging lesion detected at an outside facility, for which a consultation was requested
次要结局
- Sensitivity, Specificity, Positive and Negative Predictive Value of CEM: RC (Recombined Images) and LE (Low Energy) Images, DBT (Digital Breast Tomosynthesis), and Ultrasound Compared to Pathology as the Ground Truth.(At presentation, Day 1)
- Percentage of Lesions That Appeared Larger on CEM(One timepoint- at presentation)
- Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging(1 timepoint at presentation)
- Rate of Malignancy(One timepoint (at presentation) for lesion characterisation with 24 mo follow-up for outcome data collection)