Contrast-Enhanced Mammography (CEM) for the Evaluation and Targeted Biopsy of Suspicious Mammographic Architectural Distortions
概览
- 阶段
- 不适用
- 干预措施
- Biopsy
- 疾病 / 适应症
- Breast Carcinoma
- 发起方
- M.D. Anderson Cancer Center
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Accuracy of contrast-enhanced mammography (CEM)
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
This clinical trial examines a new imaging technology, contrast-enhanced mammography, in predicting breast cancer. Contrast-enhanced mammography is similar to standard mammography, but it includes an intravenous (by vein) injection of iodine-based contrast, which makes tissue and blood vessels more visible in scans. Contrast-enhanced mammography may work better in detecting cancer in the breast that is not seen on other imaging tests and may help doctors find the most suspicious areas of the breast to biopsy, which could increase the chances of finding breast cancer.
详细描述
PRIMARY OBJECTIVE: I. To evaluate the added value of contrast enhancement of contrast-enhanced mammography (CEM) compared to full field digital mammography (FFDM) in predicting invasive malignancy or ductal carcinoma in situ (DCIS) in patients with suspicious mammographic architectural distortion (MAD)s. SECONDARY OBJECTIVES: I. To compare sensitivity, specificity, negative predictive value and positive predictive value of CEM versus FFDM, digital breast tomosynthesis (DBT), and ultrasound (US) in predicting invasive malignancy or DCIS in patients with suspicious MADs. II. To evaluate whether the presence of enhancement on CEM correlates with the visibility of MAD on FFDM and DBT, or DBT only, and with the probability of malignancy. III. To estimate the proportion of cases in which CEM changes the original target for a stereotactic biopsy. IV. To evaluate the cancer detection rate and the outcomes (need for additional imaging, biopsies, and final pathologic results) of incidental CEM findings. EXPLORATORY OBJECTIVES: I. To evaluate the correlation of blood biomarkers and the presence of invasive cancer and DCIS on pathology in the study patients. II. To evaluate the role of CEM enhancement pattern in choosing a precise target for a stereotactic biopsy. III. To develop an objective method of quantifying the degree of enhancement above background using AI-based digital image analysis. IV. To evaluate the technical feasibility of using CEM-guided or CEM-directed stereotactic biopsies in patients with suspicious MADs. V. In patients who undergo CEM targeted or CEM directed biopsy we will evaluate the upgrade rate of DCIS to invasive malignancy or high-risk lesions to DCIS or invasive cancer for those patients who will require surgery as a part of their routine clinical care. VI. To compare the performance of FFDM (obtained as a part of the recent prior screening or diagnostic mammographic work-up) and LE CEM images (obtained as a part of the CEM study) in terms of accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the detection of invasive cancer and high-grade DCIS. OUTLINE: Patients receive iodine-based contrast agent intravenously (IV) and the undergo CEM over 10-15 minutes.
研究者
入排标准
入选标准
- •Women with suspicious MADs recommended for a stereotactic biopsy who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their biopsy at MDACC
- •Age 25-85 years
- •Willing to participate in the study, undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent
排除标准
- •Reported history of an allergic reaction to iodinated contrast
- •History of anaphylactic reaction to any substance
- •Renal insufficiency
- •Pregnancy or lactation within 6 months
- •Breast surgery affecting the site of interest within prior 6 months
- •Breast biopsy at the site of interest within the last 2 months
研究组 & 干预措施
Diagnostic (iodine-based contrast, CEM)
Patients receive iodine-based contrast agent IV and the undergo CEM over 10-15 minutes.
干预措施: Biopsy
Diagnostic (iodine-based contrast, CEM)
Patients receive iodine-based contrast agent IV and the undergo CEM over 10-15 minutes.
干预措施: Contrast-Enhanced Mammography
Diagnostic (iodine-based contrast, CEM)
Patients receive iodine-based contrast agent IV and the undergo CEM over 10-15 minutes.
干预措施: Questionnaire Administration
Diagnostic (iodine-based contrast, CEM)
Patients receive iodine-based contrast agent IV and the undergo CEM over 10-15 minutes.
干预措施: Radioactive Iodine
结局指标
主要结局
Accuracy of contrast-enhanced mammography (CEM)
时间窗: Up to 3 years
Will examine the accuracy of CEM compared to full field digital mammography (FFDM) in predicting invasive malignancy or ductal carcinoma in situ (DCIS) in patients with mammographic architectural distortion (MAD)s.
次要结局
- Sensitivity of CEM, FFDM, digital breast tomosynthesis (DBT), and ultrasound (US) in predicting invasive malignancy or DCIS(Up to 3 years)
- Proportion of cases in which CEM changes the original target for a stereotactic biopsy(Up to 3 years)
- Specificity of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS(Up to 3 years)
- Positive predictive value of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS(Up to 3 years)
- Negative predictive value of CEM, FFDM, digital breast tomosynthesis (DBT), and US in predicting invasive malignancy or DCIS(Up to 3 years)
- Degree of enhancement on CEM(Up to 3 years)
- Cancer detection rate(Up to 3 years)