Sonography Compared With MRI in Pre-Operative Evaluation of Patients With Breast Cancer to Determine Extent of Breast Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Difference between the longest diameter of the index lesion as determined by imaging versus as determined by the pathologist
研究概览
简要总结
This clinical trial studies mammography and targeted ultrasound with or without whole-breast ultrasound or contrast-enhanced magnetic resonance imaging (MRI) in finding out the extent of disease before surgery in patients with newly diagnosed breast cancer. New diagnostic imaging procedures, such as whole-breast ultrasound or contrast-enhanced MRI, may help find out how far breast cancer has spread. It is not yet known whether mammography and targeted ultrasound are more effective with or without whole-breast ultrasound or contrast-enhanced MRI in finding out how far breast cancer has spread.
详细描述
PRIMARY OBJECTIVES:
I. To determine how surgical treatment is influenced by the three imaging arms.
II. To compare three imaging arms in terms of accurately measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as gold standard).
SECONDARY OBJECTIVES:
I. In women with dense breasts: To retrospectively compare the accuracy of three imaging arms in measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as the gold standard).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Competent to provide informed consent
- •Pathologically proven invasive breast cancer or ductal carcinoma in situ (DCIS) originally identified clinically or mammographically and diagnosed by percutaneous core biopsy
- •Eligible for breast conserving surgery followed by radiation therapy
排除标准
- •Women with surgical excisional biopsy that diagnosed the breast cancer
- •Women with clinical or mammographic findings where breast conserving surgery is not an option
- •Women that clinically or mammographically have breast cancers that are fixed to skin
- •Women receiving neoadjuvant chemotherapy prior to surgery
- •Women having contraindications to contrast-enhanced (CE)-MRI examination (e.g., claustrophobia and allergy to gadolinium)
研究组 & 干预措施
Group 3 (bilateral breast contrast-enhanced MRI)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI.
干预措施: Gadolinium (Other)
Group 1 (standard of care)
Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound.
干预措施: Mammography (Procedure)
Group 1 (standard of care)
Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound.
干预措施: Therapeutic Conventional Surgery (Procedure)
Group 1 (standard of care)
Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound.
干预措施: Ultrasonography (Procedure)
Group 2 (bilateral whole-breast ultrasound)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound.
干预措施: Mammography (Procedure)
Group 2 (bilateral whole-breast ultrasound)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound.
干预措施: Therapeutic Conventional Surgery (Procedure)
Group 2 (bilateral whole-breast ultrasound)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound.
干预措施: Ultrasonography (Procedure)
Group 3 (bilateral breast contrast-enhanced MRI)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI.
干预措施: Contrast-enhanced Magnetic Resonance Imaging (Procedure)
Group 3 (bilateral breast contrast-enhanced MRI)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI.
干预措施: Mammography (Procedure)
Group 3 (bilateral breast contrast-enhanced MRI)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI.
干预措施: Therapeutic Conventional Surgery (Procedure)
Group 3 (bilateral breast contrast-enhanced MRI)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI.
干预措施: Ultrasonography (Procedure)
结局指标
主要结局
Difference between the longest diameter of the index lesion as determined by imaging versus as determined by the pathologist
时间窗: Up to 4 weeks
Every attempt will be made to identify a transformation for the difference in the lengths of the largest diameters. If none are found, then the data will be summarized with histograms, medians, quartiles, and ranges. If a transformation is found, means, standard deviations, and 95% confidence intervals will be reported instead of the median and quartiles. Differences between three imaging methods will be compared using a paired t-test (or paired rank sum test).
次要结局
- Number of patients identified with invasive breast cancer in women who have dense or no dense breasts as determined by the 3 imaging arms(Up to 4 weeks)