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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


OBJECTIVES:

- 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


DISEASE CHARACTERISTICS:

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

- 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
recommended

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Female

Menopausal status

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Cardiovascular

- No pacemaker

- No magnetic aneurysm clips

Other

- Not pregnant

- No implanted magnetic device

- No severe claustrophobia

- No other contraindications to MRI

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- At least 6 months since prior anticancer chemotherapy

Endocrine therapy

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

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Constance Lehman, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Seattle Cancer Care Alliance

Authority:

United States: Federal Government

Study ID:

CDR0000285698

NCT ID:

NCT00058058

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

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Porter Adventist HospitalDenver, Colorado  80210
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Hartford HospitalHartford, Connecticut  06102-5037
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Mayo ClinicJacksonville, Florida  32224
Simmons Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390-9063
Abramson Cancer Center at University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Seattle Cancer Care AllianceSeattle, Washington  98109
Memorial Medical CenterSpringfield, Illinois  62781
Boca Raton Community HospitalBoca Raton, Florida  33486