Magnetic Resonance Imaging (MRI) for Preoperative Staging of Patients With Invasive Lobular Carcinoma of the Breast
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in surgical management of patients with invasive lobular carcinoma of the breast and young breast cancer patients as a result of preoperative breast MRI
研究概览
简要总结
The goal of this clinical research study is to learn how often magnetic resonance imaging (MRI) of the breast locates additional areas of cancer in the breast of patients with lobular cancer as well as in the breasts of young breast cancer patients (less than age 40 years). Researchers also hope to learn how often the results of the MRI changes the type of surgical treatment that is recommended and understand the costs associated with using MRI in the diagnostic process. Researchers also want to use a different way of looking at the MRI scans to learn if they can more easily learn the difference between a cyst and a tumor.
详细描述
At MD Anderson, patients with breast cancer routinely have mammograms and ultrasounds to measure the size and extent of cancer.
MRI of the breast is a technology that is better than mammograms and ultrasounds at locating cancer. Although MRI may locate more areas of cancer, it can sometimes falsely identify normal areas of the breast as cancerous.
Unlike ductal cancer of the breast (the most common type of breast cancer), lobular cancer is more difficult to see on mammograms and ultrasounds. Therefore, patients with lobular cancer of the breast may be best suited for MRI of the breast in order to more accurately determine the extent of the cancer. In addition, in young women, because the breast tissue is very dense, all types of breast tumors are harder to detect with mammogram and ultrasound and may be better seen with MRI.
A correct measurement of the size and extent of the cancer is important because this affects the recommendation for the type of surgery a patient may have.
Study Procedures:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pure invasive lobular carcinoma or mixed invasive ductal-lobular carcinoma with the ductal component not greater that 25% OR patients under the age of 40 at diagnosis, irrespective of tumor histology
- •For women with invasive lobular carcinoma, if the pathology report from the diagnostic biopsy states that they have "predominantly" lobular histology or lobular cancer with "focal" areas/nests of ductal carcinoma, these cases will automatically be assumed to have at least 75% lobular component.
- •Women with multifocal or multicentric breast cancer are eligible if any one of the biopsy confirmed tumors meets the histologic designations outlined in Inclusion criteria #1 and #2 above.
- •Must be able to complete the MR examination within 30 days of mammography and ultrasound of the breast.
- •Age >18 years
- •Surgery planned at MDACC
- •Eastern Cooperative Oncology Group (ECOG) status 0-2
- •Creatinine and glomerular filtration rate measured or calculated within 2 weeks of MRI date
排除标准
- •Patients receiving neoadjuvant chemotherapy
- •Patients with pacemakers
- •Patients with severe claustrophobia
- •Obese patients exceeding the equipment weight limits and/or the circumference of the MRI portal
- •Interval between MRI and conventional locoregional staging studies (mammography/breast US) greater than 30 days.
- •Known allergy to gadolinium
- •Patients with clips/prostheses/implanted devices that are not MRI compatible
- •Compromised renal function, with a measured or calculated glomerular filtration rate of less than 60 ml/min/1.73m^2.
结局指标
主要结局
Change in surgical management of patients with invasive lobular carcinoma of the breast and young breast cancer patients as a result of preoperative breast MRI
时间窗: 3 years (# of times MRI changes type of surgical treatment recommended)
次要结局
未报告次要终点