Trial Outcomes & Findings for Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer (NCT NCT00058058)

Last Updated: 2019-07-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

1007 participants

Primary outcome timeframe

within 90 days of a negative mammogram of the study breast

Results posted on

2019-07-16

Participant Flow

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.

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.)

Participant milestones

Participant milestones
Measure	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. 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 Study STARTED	1007
Overall Study COMPLETED	969
Overall Study NOT COMPLETED	38

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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 Study Withdrawal by Subject	4
Overall Study Ineligible	20
Overall Study Claustrophobic	5
Overall Study technical issues	6
Overall Study Poor positioning, illness,pain	3

Baseline Characteristics

Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRI Evaluation of Contralateral Breast n=969 Participants 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.
Age, Continuous	53.3 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	969 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	925 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	23 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	48 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian Pacific Islander	2 Participants n=5 Participants
Race/Ethnicity, Customized White	887 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 90 days of a negative mammogram of the study breast

Population: All eligible participants with an analyzable MRI

Outcome measures

Outcome measures
Measure	Reference Standard Positive (RS+) n=33 Participants 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.	Reference Standard Negative (RS-) n=936 Participants 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.
MRI Diagnostic Yield of Cancers in the Contralateral Breast Test + (Final BI-RAD 0, 4, 5) · Test Positive (T+)	30 Participants	114 Participants
MRI Diagnostic Yield of Cancers in the Contralateral Breast Test + (Final BI-RAD 0, 4, 5) · Test Negative (T-)	3 Participants	822 Participants
MRI Diagnostic Yield of Cancers in the Contralateral Breast Test + (Initial MRI BI-RAD 4, 5/work-up) · Test Positive (T+)	30 Participants	105 Participants
MRI Diagnostic Yield of Cancers in the Contralateral Breast Test + (Initial MRI BI-RAD 4, 5/work-up) · Test Negative (T-)	3 Participants	831 Participants
MRI Diagnostic Yield of Cancers in the Contralateral Breast Test + (Initial MRI BI-RAD 4, 5/work-up/comp bx) · Test Positive (T+)	30 Participants	91 Participants
MRI Diagnostic Yield of Cancers in the Contralateral Breast Test + (Initial MRI BI-RAD 4, 5/work-up/comp bx) · Test Negative (T-)	3 Participants	845 Participants
MRI Diagnostic Yield of Cancers in the Contralateral Breast Test + (Initial MRI BI-RAD 0, 4, 5) · Test Positive (T+)	30 Participants	143 Participants
MRI Diagnostic Yield of Cancers in the Contralateral Breast Test + (Initial MRI BI-RAD 0, 4, 5) · Test Negative (T-)	3 Participants	793 Participants
MRI Diagnostic Yield of Cancers in the Contralateral Breast Test + (Initial MRI BI-RAD 0, 3, 4, 5) · Test Positive (T+)	31 Participants	247 Participants
MRI Diagnostic Yield of Cancers in the Contralateral Breast Test + (Initial MRI BI-RAD 0, 3, 4, 5) · Test Negative (T-)	2 Participants	689 Participants
MRI Diagnostic Yield of Cancers in the Contralateral Breast Test + (Initial MRI BI-RAD 0, 3, 4, 5/work-up)". · Test Positive (T+)	31 Participants	145 Participants
MRI Diagnostic Yield of Cancers in the Contralateral Breast Test + (Initial MRI BI-RAD 0, 3, 4, 5/work-up)". · Test Negative (T-)	2 Participants	791 Participants

SECONDARY outcome

Timeframe: within 90 days of a negative mammogram of the study breast

Population: All eligible participants with an analyzable MRI

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).

Outcome measures

Outcome measures
Measure	Reference Standard Positive (RS+) n=33 Participants 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.	Reference Standard Negative (RS-) n=936 Participants 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.
MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy Test + (Final BI-RAD 0, 4, 5)	30 Participants	114 Participants
MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy Test - (Final BI-RAD 1,2,3)	3 Participants	822 Participants

SECONDARY outcome

Timeframe: within 90 days of a negative mammogram of the study breast

Population: All eligible participants with an analyzable MRI

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.

Outcome measures

Outcome measures
Measure	Reference Standard Positive (RS+) n=33 Participants 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.	Reference Standard Negative (RS-) n=936 Participants 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.
AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast 1: Definitely not malignant	2 Participants	565 Participants
AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast 2: Probably not malignant	2 Participants	256 Participants
AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast 3: Possibly malignant	10 Participants	92 Participants
AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast 4: Probably malignant	15 Participants	21 Participants
AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast 5: Definitely malignant	4 Participants	2 Participants

Adverse Events

MRI Evaluation of Contralateral Breast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Director of Protocol Management

American College of Radiology Imaging Network

Email: Donna Hartfeil <[email protected]>

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place