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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00610181 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Procedure: MRI |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Magnetic Resonance Imaging (MRI) for Preoperative Staging of Patients With Invasive Lobular Carcinoma of the Breast |
| Estimated Enrollment: | 170 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Breast MRI
Magnetic resonance imaging (MRI) of breast for patients with invasive lobular carcinoma of the breast.
|
Procedure: MRI
MRI of both breasts, results used for surgery, then MRI repeated in 1 year as part of routine follow-up after surgery.
Other Name: MRI
|
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:
If you agree to take part in this study, you will have an MRI of both breasts.
For the MRI, part or all of the body will be passed into a long, narrow tube scanner, which is open at both ends.
The MRI images will be compared with the images from your standard of care mammogram and ultrasound images. If the MRI shows abnormalities not seen on the mammogram or ultrasound and your doctor thinks it is necessary, you may have additional testing and/or a tumor biopsy. This is part of your standard of care.
The results of this additional MRI testing will be used by your surgeon to guide his/her recommendations for your surgery.
This is an investigational study. The investigational part of this study is the comparison of the outcome of MRI images to mammogram and ultrasound images in determining appropriate surgical therapy.
Up to 170 patients will be take part in this study. All will be enrolled at MD Anderson.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with invasive lobular cancer of the breast.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Isabelle Bedrosian, MD | 713-563-1872 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Isabelle Bedrosian, MD | |
| Principal Investigator: | Isabelle Bedrosian, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00610181 History of Changes |
| Other Study ID Numbers: | 2007-0736 |
| Study First Received: | January 24, 2008 |
| Last Updated: | May 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Breast Cancer Breast Carcinoma Invasive Lobular Cancer |
Mixed Invasive Ductal-lobular Carcinoma Magnetic Resonance Imaging MRI |
|
Breast Neoplasms Carcinoma, Lobular Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary |
