ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Magnetic Resonance Imaging in Patients With Breast Cancer

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, January 2008

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

Primary Objectives:

  1. To determine whether preoperative MRI improves local staging and identifies occult carcinoma in patients with invasive lobular carcinoma.
  2. To determine the incidence of occult contralateral carcinoma in patients with invasive lobular carcinoma.

Condition Intervention
Breast Cancer
Procedure: Magnetic Resonance Imaging

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    MRI Scans   

U.S. FDA Resources

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

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

Primary Outcome Measures:
  • 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 ]

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 Study Completion Date:   January 2011
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 the 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.

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.

This is an investigational study. The investigational part of this study is the comparison of MRI images to mammogram and ultrasound images.

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:

  1. Patients with pure invasive lobular carcinoma or mixed invasive ductal-lobular carcinoma with the ductal component not greater that 25%
  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

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
  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

Responsible Party:   U.T.M.D. Anderson Cancer Center ( Isabelle Bedrosian, MD/Assistant Professor )
Study ID Numbers:   2007-0736
First Received:   January 24, 2008
Last Updated:   January 24, 2008
ClinicalTrials.gov Identifier:   NCT00610181
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer  
Invasive Lobular Cancer  
Magnetic Resonance Imaging  
MRI  

Study placed in the following topic categories:
Carcinoma, Lobular
Skin Diseases
Breast Neoplasms
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on September 08, 2008




Links to all studies - primarily for crawlers