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

• Sponsor: American College of Radiology Imaging Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT00058058
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 1,007
• Locations: 21
• Arm: 1
• Actual Duration (Months): 66
• Patients Per Site: 48
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Contralateral Breast Cancer	Procedure: MRI	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1007 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer
• Actual Study Start Date: Feb 1, 2003
• Actual Primary Completion Date: Aug 8, 2006
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. MRI Diagnostic Yield of Cancers in the Contralateral Breast [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 Outcome Measures

1. 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]

   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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
2	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
3	UCSF Comprehensive Cancer Center	San Francisco	California	United States	94115
4	Porter Adventist Hospital	Denver	Colorado	United States	80210
5	Hartford Hospital	Hartford	Connecticut	United States	06102-5037
6	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307
7	Boca Raton Community Hospital	Boca Raton	Florida	United States	33486
8	Mayo Clinic	Jacksonville	Florida	United States	32224
9	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60610
10	Memorial Medical Center	Springfield	Illinois	United States	62781
11	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21287-6681
12	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599
13	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267-0772
14	Abramson Cancer Center at University of Pennsylvania Medical Center	Philadelphia	Pennsylvania	United States	19104-4283
15	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107
16	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212-4772
17	Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390-9085
18	Cancer Center at the University of Virginia	Charlottesville	Virginia	United States	22908
19	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
20	University of Toronto	Toronto	Ontario	Canada	M5S 1A8
21	Universitaetsklinikum Bonn	Bonn		Germany	D-53105

Sponsors and Collaborators

• American College of Radiology Imaging Network
• National Cancer Institute (NCI)

Investigators

• Study Chair: Constance Lehman, MD, PhD, Seattle Cancer Care Alliance

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: American College of Radiology Imaging Network
• ClinicalTrials.gov Identifier: NCT00058058
• Other Study ID Numbers: CDR0000285698; ACRIN-6667; U01CA079778; U01CA080098
• First Posted: Apr 9, 2003
• Last Update Posted: Jul 16, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by American College of Radiology Imaging Network: 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
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Recruitment Details	The data includes information on 1007 participants enrolled between April 1, 2003 and June 10, 2004 at 25 centers for data collected through August 8, 2006.
Pre-assignment Detail	Patients were not imaged by MRI if they did not meet eligibility criteria, withdrew, or were otherwise unable to be scanned (claustrophobic, too large for scanner, illness, etc.)

Arm/Group Title	MRI Evaluation of Contralateral Breast
Arm/Group 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. 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.
Period Title: Overall Study
STARTED	1007
COMPLETED	969
NOT COMPLETED	38

Baseline Characteristics

Arm/Group Title	MRI Evaluation of Contralateral Breast
Arm/Group 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. 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.
Overall Participants	969
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.3 (11.4)
Sex: Female, Male (Count of Participants)
Female	969 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	38 3.9%
Not Hispanic or Latino	925 95.5%
Unknown or Not Reported	6 0.6%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaskan Native	2 0.2%
Asian	23 2.4%
Black or African American	48 5%
Native Hawaiian Pacific Islander	2 0.2%
White	887 91.5%
Unknown	14 1.4%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All eligible participants with an analyzable MRI

Arm/Group Title	Reference Standard Positive (RS+)	Reference Standard Negative (RS-)
Arm/Group Description	Reference Standard Positive indicates a breast cancer diagnosed in the contralateral (study) breast. Participants who received a diagnosis of ductal carcinoma in situ or any invasive breast cancer as a result of a biopsy or surgery that was performed within 365 days of the initial MRI scan were considered positive for cancer. Participants were considered positive only on the basis of positive tissue diagnosis.	Women with no diagnosis of cancer during the year after their enrollment were considered negative. All cases for whom no tissue diagnosis of cancer was reported during the 365 days following the initial MRI were considered negative, regardless of whether any additional imaging had been performed.
Measure Participants	33	936
Test Positive (T+)	30 3.1%	114 NaN
Test Negative (T-)	3 0.3%	822 NaN
Test Positive (T+)	30 3.1%	105 NaN
Test Negative (T-)	3 0.3%	831 NaN
Test Positive (T+)	30 3.1%	91 NaN
Test Negative (T-)	3 0.3%	845 NaN
Test Positive (T+)	30 3.1%	143 NaN
Test Negative (T-)	3 0.3%	793 NaN
Test Positive (T+)	31 3.2%	247 NaN
Test Negative (T-)	2 0.2%	689 NaN
Test Positive (T+)	31 3.2%	145 NaN
Test Negative (T-)	2 0.2%	791 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Reference Standard Positive (RS+)
	Comments	Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 based on Final BI-RADS
	Type of Statistical Test	Other
	Comments	Estimation of diagnostic yield
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Binomial proportion
	Estimated Value	0.031
	Confidence Interval	(2-Sided) 95%; 0.020 to 0.042
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.006
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Reference Standard Positive (RS+)
	Comments	Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Binomial Proportion
	Estimated Value	0.031
	Confidence Interval	(2-Sided) 95%; 0.021 to 0.044
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.006
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Reference Standard Positive (RS+)
	Comments	Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up and a completed biopsy procedure
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Binomial Proportion
	Estimated Value	0.031
	Confidence Interval	(2-Sided) 95%; 0.020 to 0.042
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.006
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Reference Standard Positive (RS+)
	Comments	Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 on the initial MRI scan
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Binomial proportion
	Estimated Value	0.031
	Confidence Interval	(2-Sided) 95%; 0.020 to 0.042
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.006
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Reference Standard Positive (RS+)
	Comments	Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 on the initial MRI scan
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Binomial Proportion
	Estimated Value	0.032
	Confidence Interval	(2-Sided) 95%; 0.021 to 0.043
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.006
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Reference Standard Positive (RS+)
	Comments	Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 based on initial MRI and subsequent work-up
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Binomial Proportion
	Estimated Value	0.032
	Confidence Interval	(2-Sided) 95%; 0.021 to 0.043
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.006
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All eligible participants with an analyzable MRI

Arm/Group Title	Reference Standard Positive (RS+)	Reference Standard Negative (RS-)
Arm/Group Description	Reference Standard Positive indicates a breast cancer diagnosed in the contralateral (study) breast. Participants who received a diagnosis of ductal carcinoma in situ or any invasive breast cancer as a result of a biopsy or surgery that was performed within 365 days of the initial MRI scan were considered positive for cancer. Participants were considered positive only on the basis of positive tissue diagnosis.	Women with no diagnosis of cancer during the year after their enrollment were considered negative. All cases for whom no tissue diagnosis of cancer was reported during the 365 days following the initial MRI were considered negative, regardless of whether any additional imaging had been performed.
Measure Participants	33	936
Test + (Final BI-RAD 0, 4, 5)	30 3.1%	114 NaN
Test - (Final BI-RAD 1,2,3)	3 0.3%	822 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Reference Standard Positive (RS+)
	Comments	Sensitivity estimate - estimates the P(T+|D+) where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Binomial Proportion
	Estimated Value	0.9091
	Confidence Interval	(2-Sided) 95%; 0.7567 to 0.9809
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.05004
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Reference Standard Negative (RS-)
	Comments	Specificity - estimates the P(T-|D-) of MRI where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Binomial Proportion
	Estimated Value	.8782
	Confidence Interval	(2-Sided) 95%; 0.8555 to 0.8985
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0107
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Reference Standard Positive (RS+), Reference Standard Negative (RS-)
	Comments	PPV estimate - estimates the P(D+|T+), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D).
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Binomial Proportion
	Estimated Value	.2083
	Confidence Interval	(2-Sided) 95%; 0.1452 to 0.2839
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0338
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Reference Standard Positive (RS+), Reference Standard Negative (RS-)
	Comments	B. NPV Analysis for ALL Cases in Analysis Set NPV estimate - estimates the P(D-|T-), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Binomial Proportion
	Estimated Value	0.9964
	Confidence Interval	(2-Sided) 95%; 0.9894 to 0.9993
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0021
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Reference Standard Positive (RS+), Reference Standard Negative (RS-)
	Comments	B. Diagnostic Yield for ALL Cases in Analysis Set Diagnostic Yield - estimates the likelihood that the MRI within 90 days of a negative mammogram will provide the information needed to establish a diagnosis
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Binomial Proportion
	Estimated Value	0.0310
	Confidence Interval	(2-Sided) 95%; 0.021 to 0.044
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.00556
	Estimation Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All eligible participants with an analyzable MRI

Arm/Group Title	Reference Standard Positive (RS+)	Reference Standard Negative (RS-)
Arm/Group Description	Reference Standard Positive indicates a breast cancer diagnosed in the contralateral (study) breast. Participants who received a diagnosis of ductal carcinoma in situ or any invasive breast cancer as a result of a biopsy or surgery that was performed within 365 days of the initial MRI scan were considered positive for cancer. Participants were considered positive only on the basis of positive tissue diagnosis.	Women with no diagnosis of cancer during the year after their enrollment were considered negative. All cases for whom no tissue diagnosis of cancer was reported during the 365 days following the initial MRI were considered negative, regardless of whether any additional imaging had been performed.
Measure Participants	33	936
1: Definitely not malignant	2 0.2%	565 NaN
2: Probably not malignant	2 0.2%	256 NaN
3: Possibly malignant	10 1%	92 NaN
4: Probably malignant	15 1.5%	21 NaN
5: Definitely malignant	4 0.4%	2 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Reference Standard Positive (RS+), Reference Standard Negative (RS-)
	Comments	ROC analysis - estimates the accuracy of MRI within 90 days of a negative mammogram to detect cancer in the contralateral breast
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	ROC analysis
	Estimated Value	0.9355
	Confidence Interval	(2-Sided) 95%; 0.8956 to 0.9753
	Parameter Dispersion	Type: Value:
	Estimation Comments	exact CI

Adverse Events

Time Frame	30 DAYS POST Intervention
Arm/Group Title	MRI Evaluation of Contralateral Breast
Arm/Group 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. 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.
All Cause Mortality
	MRI Evaluation of Contralateral Breast
	Affected / at Risk (%)	# Events
Total	0/1007 (0%)
Serious Adverse Events
	MRI Evaluation of Contralateral Breast
	Affected / at Risk (%)	# Events
Total	0/1007 (0%)
Other (Not Including Serious) Adverse Events
	MRI Evaluation of Contralateral Breast
	Affected / at Risk (%)	# Events
Total	0/1007 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.