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MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer

18 Years
Not Enrolling
Breast Cancer

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Trial Information

MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer


- Determine the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the
contralateral breast of women with a recent unilateral diagnosis of breast cancer and a
negative contralateral mammogram and clinical breast exam.

- Determine the sensitivity, specificity, positive predictive value for both call backs
for additional imaging and biopsy recommendations, and receiver operating
characteristic curves of MRI in evaluating these patients.

- Determine the effect of the following patient-related factors: age (50 years old and
over vs less than 50 years old), breast parenchymal density (fatty vs non fatty
breast), and tumor histology (invasive lobular vs invasive ductal, invasive vs in situ)
on the performance of MRI (cancer yield, sensitivity, specificity, and PPV).

OUTLINE: This is a multicenter study.

Patients receive gadopentetate dimeglumine IV and then undergo magnetic resonance imaging of
the contralateral breast.

Patients are followed at 12-18 and 24-30 months.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Inclusion Criteria


- Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the

- Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days

- Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign
clinical breast exam of the contralateral breast within the past 90 days

- Prior biopsy of the contralateral breast (including FNA) is allowed provided it was
performed at least 6 months prior to study entry

- Prior magnetic resonance exam of the contralateral breast is allowed provided it was
performed at least 1 year prior to study entry

- No remote history of breast cancer

- No new breast symptoms within the past 60 days for which further evaluation is

- Hormone receptor status:

- Not specified



- 18 and over


- Female

Menopausal status

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- No pacemaker

- No magnetic aneurysm clips


- Not pregnant

- No implanted magnetic device

- No severe claustrophobia

- No other contraindications to MRI

- No psychiatric, psychological, or other condition that would preclude informed


Biologic therapy

- Not specified


- At least 6 months since prior anticancer chemotherapy

Endocrine therapy

- No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors
(preventive therapy allowed)


- Not specified


- Not specified

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Constance Lehman, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Seattle Cancer Care Alliance


United States: Federal Government

Study ID:




Start Date:

February 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • invasive ductal breast carcinoma
  • invasive lobular breast carcinoma
  • breast cancer in situ
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
Porter Adventist Hospital Denver, Colorado  80210
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Hartford Hospital Hartford, Connecticut  06102-5037
Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772
UCSF Comprehensive Cancer Center San Francisco, California  94115
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Mayo Clinic Jacksonville, Florida  32224
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390-9063
Abramson Cancer Center at University of Pennsylvania Medical Center Philadelphia, Pennsylvania  19104
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Seattle Cancer Care Alliance Seattle, Washington  98109
Memorial Medical Center Springfield, Illinois  62781
Boca Raton Community Hospital Boca Raton, Florida  33486