Magnetic Resonance Imaging in Patients With Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00610181
First received: January 24, 2008
Last updated: October 1, 2014
Last verified: October 2014
  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. 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.


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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 3 years (# of times MRI changes type of surgical treatment recommended) ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: January 2008
Estimated Primary Completion Date: January 2016 (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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with invasive lobular cancer of the breast.

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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610181

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Isabelle Bedrosian, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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: October 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Breast Carcinoma
Invasive Lobular Cancer
Mixed Invasive Ductal-lobular Carcinoma
Magnetic Resonance Imaging
MRI

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Lobular
Adenocarcinoma
Breast Diseases
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Skin Diseases

ClinicalTrials.gov processed this record on October 30, 2014