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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,007

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline

Completed

Started Feb 2003

Longer than P75 for not_applicable breast-cancer

Geographic Reach

3 countries

21 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.5 years study duration

Study Start

First participant enrolled

February 1, 2003

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2003

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2006

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed

10 years until next milestone

Results Posted

Study results publicly available

July 27, 2018

Completed

Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

3.5 years

First QC Date

April 7, 2003

Results QC Date

December 24, 2017

Last Update Submit

July 2, 2019

Conditions

Breast Cancer Contralateral Breast Cancer

Keywords

ductal breast carcinoma in situinvasive ductal breast carcinomainvasive lobular breast carcinomabreast cancer in situstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerMagnetic resonance imagingMRI

Outcome Measures

Primary Outcomes (1)

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: 1. The initial BI-RADs: from the MRI of the contralateral breast 2. 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). 3. 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 4. 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 Outcomes (2)

MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy
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
within 90 days of a negative mammogram of the study breast

Study Arms (1)

MRI Evaluation of Contralateral Breast

EXPERIMENTAL

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

Interventions

MRIPROCEDURE

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.

Also known as: magnetic resonance imaging

MRI Evaluation of Contralateral Breast

Eligibility Criteria

Age18 Years - 120 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

American College of Radiology Imaging Networklead
National Cancer Institute (NCI)collaborator

Study Sites (21)

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Boca Raton Community Hospital

Boca Raton, Florida, 33486, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60610, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287-6681, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0772, United States

Location

Abramson Cancer Center at University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390-9085, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

University of Toronto

Toronto, Ontario, M5S 1A8, Canada

Location

Universitaetsklinikum Bonn

Bonn, D-53105, Germany

Location

Related Publications (3)

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.
PMID: 22915431RESULT
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.
PMID: 20501712RESULT
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.
PMID: 17392300RESULT

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingCarcinoma, Ductal, BreastCarcinoma, LobularBreast Carcinoma In Situ

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryCarcinoma, Ductal

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title: Senior Director of Protocol Management
Organization: American College of Radiology Imaging Network

Study Officials

Constance Lehman, MD, PhD
Seattle Cancer Care Alliance
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: NETWORK
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

February 1, 2003

Primary Completion

August 8, 2006

Study Completion

August 1, 2008

Last Updated

July 16, 2019

Results First Posted

July 27, 2018

Record last verified: 2019-07

Locations

DE(1)US(19)CA(1)

Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

MRI Evaluation of Contralateral Breast

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (21)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

MRI Evaluation of Contralateral Breast

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (21)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations