Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer

Breast Cancer Clinical Trial

— ACRIN-6667  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058058
• Other study ID #: CDR0000285698
• Secondary ID: ACRIN-6667U01CA0
• Status: Completed
• Phase: N/A
• Start date: February 2003
• Est. completion date: August 2008

Study information

• Verified date: July 2019
• Source: American College of Radiology Imaging Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1007
• Est. completion date: August 2008
• Est. primary completion date: August 8, 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Contralateral Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario
Germany	Universitaetsklinikum Bonn	Bonn
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Boca Raton Community Hospital	Boca Raton	Florida
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	Porter Adventist Hospital	Denver	Colorado
United States	Hartford Hospital	Hartford	Connecticut
United States	Mayo Clinic	Jacksonville	Florida
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Abramson Cancer Center at University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Memorial Medical Center	Springfield	Illinois
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology Imaging Network	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

References & 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):W386-9 — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

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