Clinical trial NCT00610181: Magnetic Resonance Imaging in Patients With Breast Cancer
Official title: Magnetic Resonance Imaging (MRI) for Preoperative Staging of Patients With Invasive Lobular Carcinoma of the Breast
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Breast Carcinoma
Invasive Lobular Cancer
Mixed Invasive Ductal-lobular Carcinoma
Magnetic Resonance Imaging
MRI
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2008-02-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with invasive lobular cancer of the breast.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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. Eastern Cooperative Oncology Group (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.

Primary outcomes:
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
timeFrame: 3 years (# of times MRI changes type of surgical treatment recommended)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Isabelle Bedrosian, MD
role: PRINCIPAL_INVESTIGATOR
References: