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Magnetic Resonance Imaging in Patients With Breast Cancer
This study is currently recruiting participants.
Study NCT00610181   Information provided by M.D. Anderson Cancer Center
First Received: January 24, 2008   Last Updated: May 20, 2009   History of Changes

January 24, 2008
May 20, 2009
January 2008
January 2011   (final data collection date for primary outcome measure)
To learn how often magnetic resonance imaging (MRI) of the breast locates additional areas of cancer in the breast of patients with lobular cancer. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
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. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00610181 on ClinicalTrials.gov Archive Site
To learn how often the results of the MRI changes the type of surgery that is recommended. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Same as current
 
Magnetic Resonance Imaging in Patients With Breast Cancer
Magnetic Resonance Imaging (MRI) for Preoperative Staging of Patients With Invasive Lobular Carcinoma of the Breast

Objectives:

  1. To determine whether preoperative MRI improves local staging and identifies occult carcinoma in patients with invasive lobular carcinoma or in young breast cancer patients who will be surgically treated.
  2. To determine the incidence of occult contralateral carcinoma in patients with invasive lobular carcinoma or in young breast cancer patients

At M. D. 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.

MRI will be repeated in 1 year as part of your routine follow-up after 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 150 patients will be take part in this study. All will be enrolled at M. D. Anderson.

 
Observational
Case-Only, Prospective
Breast Cancer
Procedure: Magnetic Resonance Imaging
Patients with invasive lobular carcinoma of the breast.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
150
 
January 2011   (final data collection date for primary outcome measure)

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. Must be able to complete the MR examination within 30 days of mammography and ultrasound of the breast.
  3. Age >18 years
  4. Surgery planned at MDACC
  5. ECOG status 0-2
  6. Creatinine and glomerular filtration rate measured 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 calculated glomerular filtration rate of less than 60 ml/min/1.73m^2.
Both
18 Years and older
No
Contact: Isabelle Bedrosian, MD 713-563-1872
United States
 
NCT00610181
Isabelle Bedrosian, MD/Assistant Professor, U.T.M.D. Anderson Cancer Center
2007-0736
M.D. Anderson Cancer Center
 
Principal Investigator: Isabelle Bedrosian, MD U.T.M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP