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Completed

NCT Number: NCT00058058

Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer

RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral breast cancer.

PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer.

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Ductal Carcinoma, Ductal, Breast Carcinoma, Intraductal, Noninfiltrating Carcinoma, Lobular Contralateral Breast Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–120 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Toronto, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Procedure

Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study.

Other names: magnetic resonance imaging

Primary outcomes

  1. MRI Diagnostic Yield of Cancers in the Contralateral Breast

    Time frame: within 90 days of a negative mammogram of the study breast

    To assess 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.

    the "Test" status was defined based on combinations of the following 4 factors:

    • The initial BI-RADs: from the MRI of the contralateral breast
    • The final BI-RADs: determined after all subsequent work-up and follow-up within 365 from the initial MRI (an explicit recommendation for biopsy always resulted in a final BI-RADs of 4).
    • Subsequent work-up includes all procedures resultant from an Initial MRI finding (generally triggered by a BI-RADs 0 or 3) within 365 from the initial MRI
    • Whether or not biopsy procedure (Bx) were performed on the contralateral (Study) breast within 365 from the initial MRI

Secondary outcomes

  1. MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy

    Time frame: within 90 days of a negative mammogram of the study breast

    Accuracy values (Sensitivity, Specificity, Positive Predicative Value (PPV), Negative Predictive Value (NPV), Diagnostic Yield, and Area Under the Curve (AUC)) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as either the Probability of malignancy from the initial MRI interpretation (for AUC) or the "Final BI-RADs", where the final BI-RADS is defined as the BI-RADS assigned after all subsequent work-up and follow-up within 365 from the initial MRI are complete (an explicit recommendation for biopsy always results in a final BI-RADs of 4).

  2. AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast

    Time frame: within 90 days of a negative mammogram of the study breast

    Area Under the Curve (AUC) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as the Probability of malignancy from the initial MRI interpretation.

Sponsors and collaborators

Lead sponsor

American College of Radiology Imaging Network

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: ACRIN-6667

Important dates

Study start
2003
Primary completion
2006
Study completion
2008
First posted
Apr 9, 2003
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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