NCT00610181

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

7.4 years

First QC Date

January 24, 2008

Last Update Submit

June 29, 2015

Conditions

Breast Cancer

Keywords

Breast CancerBreast CarcinomaInvasive Lobular CancerMixed Invasive Ductal-lobular CarcinomaMagnetic Resonance ImagingMRI

Outcome Measures

Primary Outcomes (1)

  • 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

    3 years (# of times MRI changes type of surgical treatment recommended)

Study Arms (1)

Breast MRI

Magnetic resonance imaging (MRI) of breast for patients with invasive lobular carcinoma of the breast.

Procedure: MRI

Interventions

MRIPROCEDURE

MRI of both breasts, results used for surgery, then MRI repeated in 1 year as part of routine follow-up after surgery.

Breast MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with invasive lobular cancer of the breast.

You may qualify if:

  • 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
  • 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.
  • 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
  • Eastern Cooperative Oncology Group (ECOG) status 0-2
  • Creatinine and glomerular filtration rate measured or calculated within 2 weeks of MRI date

You may not qualify if:

  • 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 measured or calculated glomerular filtration rate of less than 60 ml/min/1.73m\^2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Isabelle Bedrosian, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 7, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2015

Last Updated

July 1, 2015

Record last verified: 2015-06

Locations

US(1)