Magnetic Resonance Imaging in Patients With Breast Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00610181

Purpose

Objectives:

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.
To determine the incidence of occult contralateral carcinoma in patients with invasive lobular carcinoma or in young breast cancer patients

Condition	Intervention
Breast Cancer	Procedure: Magnetic Resonance Imaging

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Magnetic Resonance Imaging (MRI) for Preoperative Staging of Patients With Invasive Lobular Carcinoma of the Breast

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer MRI Scans

U.S. FDA Resources

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

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	January 2008
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with invasive lobular carcinoma of the breast.	Procedure: Magnetic Resonance Imaging Magnetic Resonance Imaging of both breasts.

Detailed Description:

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.

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:

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
Must be able to complete the MR examination within 30 days of mammography and ultrasound of the breast.
Age >18 years
Surgery planned at MDACC
ECOG status 0-2
Creatinine and glomerular filtration rate measured within 2 weeks of MRI date

Exclusion Criteria:

Patients receiving neoadjuvant chemotherapy
Patients with pacemakers
Patients with severe claustrophobia
Obese patients exceeding the equipment weight limits and/or the circumference of the MRI portal
Interval between MRI and conventional locoregional staging studies (mammography/breast US) greater than 30 days.
Known allergy to gadolinium
Patients with clips/prostheses/implanted devices that are not MRI compatible
Compromised renal function, with a calculated glomerular filtration rate of less than 60 ml/min/1.73m^2.

Contacts and Locations

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

Contacts

Contact: Isabelle Bedrosian, MD

713-563-1872

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Isabelle Bedrosian, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Isabelle Bedrosian, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Isabelle Bedrosian, MD/Assistant Professor )
Study ID Numbers:	2007-0736
Study First Received:	January 24, 2008
Last Updated:	May 20, 2009
ClinicalTrials.gov Identifier:	NCT00610181 History of Changes
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:

Carcinoma, Lobular
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Skin Diseases
Breast Neoplasms

Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 25, 2009