An interventional study of MRI in Breast Cancer and Contralateral Breast Cancer, sponsored by American College of Radiology Imaging Network. Completed at 21 sites in 3 countries. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-07-16.
Sponsored by American College of Radiology Imaging Network · Not applicable, Interventional, and Diagnostic
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.
OBJECTIVES:
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 1,007 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →American College of Radiology Imaging Network is the lead sponsor of 21 studies on the registry; none are open to participants now.
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DISEASE CHARACTERISTICS:
Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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.
Also known as: magnetic resonance imaging
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
Time frame: within 90 days of a negative mammogram of the study breast
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).
Time frame: 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
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
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.
| Milestone | MRI Evaluation of Contralateral Breast |
|---|---|
| Started | 1007 |
| Completed | 969 |
| Not completed | 38 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Ineligible | 20 |
| Withdrew: Claustrophobic | 5 |
| Withdrew: Technical issues | 6 |
| Withdrew: Poor positioning, illness,pain | 3 |
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
| Participants | Reference Standard Positive (RS+) | Reference Standard Negative (RS-) |
|---|---|---|
| Test + (Final BI-RAD 0, 4, 5) — Test Positive (T+) | 30 | 114 |
| Test + (Final BI-RAD 0, 4, 5) — Test Negative (T-) | 3 | 822 |
| Test + (Initial MRI BI-RAD 4, 5/work-up) — Test Positive (T+) | 30 | 105 |
| Test + (Initial MRI BI-RAD 4, 5/work-up) — Test Negative (T-) | 3 | 831 |
| Test + (Initial MRI BI-RAD 4, 5/work-up/comp bx) — Test Positive (T+) | 30 | 91 |
| Test + (Initial MRI BI-RAD 4, 5/work-up/comp bx) — Test Negative (T-) | 3 | 845 |
| Test + (Initial MRI BI-RAD 0, 4, 5) — Test Positive (T+) | 30 | 143 |
| Test + (Initial MRI BI-RAD 0, 4, 5) — Test Negative (T-) | 3 | 793 |
| Test + (Initial MRI BI-RAD 0, 3, 4, 5) — Test Positive (T+) | 31 | 247 |
| Test + (Initial MRI BI-RAD 0, 3, 4, 5) — Test Negative (T-) | 2 | 689 |
| Test + (Initial MRI BI-RAD 0, 3, 4, 5/work-up)". — Test Positive (T+) | 31 | 145 |
| Test + (Initial MRI BI-RAD 0, 3, 4, 5/work-up)". — Test Negative (T-) | 2 | 791 |
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).
| Participants | Reference Standard Positive (RS+) | Reference Standard Negative (RS-) |
|---|---|---|
| Test + (Final BI-RAD 0, 4, 5) | 30 | 114 |
| Test - (Final BI-RAD 1,2,3) | 3 | 822 |
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.
| Participants | Reference Standard Positive (RS+) | Reference Standard Negative (RS-) |
|---|---|---|
| 1: Definitely not malignant | 2 | 565 |
| 2: Probably not malignant | 2 | 256 |
| 3: Possibly malignant | 10 | 92 |
| 4: Probably malignant | 15 | 21 |
| 5: Definitely malignant | 4 | 2 |
Collected over 30 DAYS POST Intervention. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MRI Evaluation of Contralateral Breast | 0/1,007 (0%) | 0/1,007 (0%) | 0/1,007 (0%) |
| Age, Continuous(years) | MRI Evaluation of Contralateral Breast |
|---|---|
| Mean | 53.3 ± 11.4 |
| Sex: Female, Male(Participants) | MRI Evaluation of Contralateral Breast |
|---|---|
| Female | 969 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | MRI Evaluation of Contralateral Breast |
|---|---|
| Hispanic or Latino | 38 |
| Not Hispanic or Latino | 925 |
| Unknown or Not Reported | 6 |
| Race/Ethnicity, Customized(Participants) | MRI Evaluation of Contralateral Breast |
|---|---|
| American Indian or Alaskan Native | 2 |
| Asian | 23 |
| Black or African American | 48 |
| Native Hawaiian Pacific Islander | 2 |
| White | 887 |
| Unknown | 14 |
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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American College of Radiology Imaging Network