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

Primary Purpose

Breast Cancer, Contralateral Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MRI
Sponsored by
American College of Radiology Imaging Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring 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, Magnetic resonance imaging, MRI

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Jonsson Comprehensive Cancer Center, UCLA
  • UCSF Comprehensive Cancer Center
  • Porter Adventist Hospital
  • Hartford Hospital
  • Walter Reed Army Medical Center
  • Boca Raton Community Hospital
  • Mayo Clinic
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Memorial Medical Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Charles M. Barrett Cancer Center at University Hospital
  • Abramson Cancer Center at University of Pennsylvania Medical Center
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Allegheny General Hospital
  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Cancer Center at the University of Virginia
  • Seattle Cancer Care Alliance
  • University of Toronto
  • Universitaetsklinikum Bonn

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI Evaluation of Contralateral Breast

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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.

Full Information

First Posted
April 7, 2003
Last Updated
July 2, 2019
Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00058058
Brief Title
Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
Acronym
ACRIN-6667
Official Title
MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2003 (Actual)
Primary Completion Date
August 8, 2006 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Contralateral Breast Cancer
Keywords
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, Magnetic resonance imaging, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1007 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI Evaluation of Contralateral Breast
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
MRI
Other Intervention Name(s)
magnetic resonance imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
MRI Diagnostic Yield of Cancers in the Contralateral Breast
Description
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
Time Frame
within 90 days of a negative mammogram of the study breast
Secondary Outcome Measure Information:
Title
MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy
Description
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).
Time Frame
within 90 days of a negative mammogram of the study breast
Title
AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast
Description
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.
Time Frame
within 90 days of a negative mammogram of the study breast

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance Lehman, MD, PhD
Organizational Affiliation
Seattle Cancer Care Alliance
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102-5037
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States
Facility Name
Boca Raton Community Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-6681
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0772
Country
United States
Facility Name
Abramson Cancer Center at University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4772
Country
United States
Facility Name
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9085
Country
United States
Facility Name
Cancer Center at the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1A8
Country
Canada
Facility Name
Universitaetsklinikum Bonn
City
Bonn
ZIP/Postal Code
D-53105
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22915431
Citation
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.
Results Reference
result
PubMed Identifier
20501712
Citation
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.
Results Reference
result
PubMed Identifier
17392300
Citation
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.
Results Reference
result
Links:
URL
http://clinicaltrials.gov/
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer

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