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Magnetic Resonance Imaging (MRI) for Preoperative Staging of Patients With Invasive Lobular Carcinoma of the Breast

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Magnetic Resonance Imaging (MRI) for Preoperative Staging of Patients With Invasive Lobular Carcinoma of the Breast

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.

Information like your age, diagnosis, and results of your testing will be collected as part
of the data analysis for this study.

No identifying information will be sent outside of MD Anderson. Your information will be
stored on a password-protected computer. Information may be kept for up to 5 years after
the study ends.

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.

Inclusion Criteria:

1. 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

2. 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.

3. 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.

4. Must be able to complete the MR examination within 30 days of mammography and
ultrasound of the breast.

5. Age >18 years

6. Surgery planned at MDACC

7. ECOG status 0-2

8. Creatinine and glomerular filtration rate measured or calculated within 2 weeks of
MRI date

Exclusion Criteria:

1. Patients receiving neoadjuvant chemotherapy

2. Patients with pacemakers

3. Patients with severe claustrophobia

4. Obese patients exceeding the equipment weight limits and/or the circumference of the
MRI portal

5. Interval between MRI and conventional locoregional staging studies
(mammography/breast US) greater than 30 days.

6. Known allergy to gadolinium

7. Patients with clips/prostheses/implanted devices that are not MRI compatible

8. Compromised renal function, with a measured or calculated glomerular filtration rate
of less than 60 ml/min/1.73m^2.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

3 years (# of times MRI changes type of surgical treatment recommended)

Safety Issue:


Principal Investigator

Isabelle Bedrosian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Carcinoma
  • Invasive Lobular Cancer
  • Mixed Invasive Ductal-lobular Carcinoma
  • Magnetic Resonance Imaging
  • MRI
  • Breast Neoplasms
  • Carcinoma, Lobular



UT MD Anderson Cancer Center Houston, Texas  77030