Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer (ACRIN-6667)

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Contralateral Breast Cancer
• Intervention / Treatment: Procedure: MRI

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1007
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1A8
      • University of Toronto
• Germany
  • Bonn, Germany, D-53105
    • Universitaetsklinikum Bonn
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • California
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center, UCLA
    • San Francisco, California, United States, 94115
      • UCSF Comprehensive Cancer Center
  • Colorado
    • Denver, Colorado, United States, 80210
      • Porter Adventist Hospital
  • Connecticut
    • Hartford, Connecticut, United States, 06102-5037
      • Hartford Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20307
      • Walter Reed Army Medical Center
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Community Hospital
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    • Springfield, Illinois, United States, 62781
      • Memorial Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287-6681
      • Sidney kimmel comprehensive cancer center at johns hopkins
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0772
      • Charles M. Barrett Cancer Center at University Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • Abramson Cancer Center at University of Pennsylvania Medical Center
    • Pittsburgh, Pennsylvania, United States, 15212-4772
      • Allegheny General Hospital
  • Texas
    • Dallas, Texas, United States, 75390-9085
      • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Cancer Center at the University of Virginia
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 118 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MRI Evaluation of Contralateral Breast; The cohort is a distinct population of women at high risk for breast carcinoma: women with a recent (within 60 days) personal diagnosis of breast cancer who will have MRI to evaluate the contralateral breast.

Procedure: MRI; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI Diagnostic Yield of Cancers in the Contralateral 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	within 90 days of a negative mammogram of the study breast

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy	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).	within 90 days of a negative mammogram of the study breast
AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral 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.	within 90 days of a negative mammogram of the study breast

Collaborators and Investigators

• Sponsor: American College of Radiology Imaging Network
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Constance Lehman, MD, PhD, Seattle Cancer Care Alliance

Publications and helpful links

General Publications

• DeMartini WB, Hanna L, Gatsonis C, Mahoney MC, Lehman CD. Evaluation of tissue sampling methods used for MRI-detected contralateral breast lesions in the American College of Radiology Imaging Network 6667 trial. AJR Am J Roentgenol. 2012 Sep;199(3):W386-91. doi: 10.2214/AJR.11.7000.
• Weinstein SP, Hanna LG, Gatsonis C, Schnall MD, Rosen MA, Lehman CD. Frequency of malignancy seen in probably benign lesions at contrast-enhanced breast MR imaging: findings from ACRIN 6667. Radiology. 2010 Jun;255(3):731-7. doi: 10.1148/radiol.10081712.
• Lehman CD, Gatsonis C, Kuhl CK, Hendrick RE, Pisano ED, Hanna L, Peacock S, Smazal SF, Maki DD, Julian TB, DePeri ER, Bluemke DA, Schnall MD; ACRIN Trial 6667 Investigators Group. MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer. N Engl J Med. 2007 Mar 29;356(13):1295-303. doi: 10.1056/NEJMoa065447. Epub 2007 Mar 28.

Helpful Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2003
• Primary Completion (Actual): August 8, 2006
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: April 7, 2003
• First Submitted That Met QC Criteria: April 8, 2003
• First Posted (Estimate): April 9, 2003

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: MRI; stage IV breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; Magnetic resonance imaging; stage II breast cancer; stage IIIC breast cancer; stage I breast cancer; breast cancer in situ; ductal breast carcinoma in situ; invasive ductal breast carcinoma; invasive lobular breast carcinoma
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CDR0000285698; U01CA080098 (U.S. NIH Grant/Contract); U01CA079778 (U.S. NIH Grant/Contract); ACRIN-6667 (Other Identifier: American College of Radiology Imaging Network)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No