Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ACRIN-6667 | Other Identifier | American College of Radiology Imaging Network | |
| U01CA079778 | U.S. NIH Grant/Contract | View source | |
| U01CA080098 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| within 90 days of a negative mammogram of the study breast |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
DISEASE CHARACTERISTICS:
Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Constance Lehman, MD, PhD | Seattle Cancer Care Alliance | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22915431 | Result | 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. | |
| 20501712 | Result | 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. |
| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
Not provided
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.)
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. | within 90 days of a negative mammogram of the study breast |
| Jonsson Comprehensive Cancer Center, UCLA |
| Los Angeles |
| California |
| 90095-1781 |
| United States |
| UCSF Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Porter Adventist Hospital | Denver | Colorado | 80210 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102-5037 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States |
| Boca Raton Community Hospital | Boca Raton | Florida | 33486 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60610 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287-6681 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267-0772 | United States |
| Abramson Cancer Center at University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104-4283 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212-4772 | United States |
| Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390-9085 | United States |
| Cancer Center at the University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| University of Toronto | Toronto | Ontario | M5S 1A8 | Canada |
| Universitaetsklinikum Bonn | Bonn | D-53105 | Germany |
| 17392300 | Result | 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. |
| COMPLETED | Completed MRI |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| All eligible participants with an analyzable MRI | Posted | Count of Participants | Participants | 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). | All eligible participants with an analyzable MRI | Posted | Count of Participants | Participants | 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. | All eligible participants with an analyzable MRI | Posted | Count of Participants | Participants | within 90 days of a negative mammogram of the study breast |
|
30 DAYS POST Intervention
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 1,007 | 0 | 1,007 | 0 | 1,007 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Protocol Management | American College of Radiology Imaging Network | Donna Hartfeil <dhartfeil@acr.org> |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D018270 | Carcinoma, Ductal, Breast |
| D018275 | Carcinoma, Lobular |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D044584 | Carcinoma, Ductal |
Not provided
Not provided
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Unknown or Not Reported |
|
| Black or African American |
|
| Native Hawaiian Pacific Islander |
|
| White |
|
| Unknown |
|
| Test + (Initial MRI BI-RAD 4, 5/work-up) |
|
| Test + (Initial MRI BI-RAD 4, 5/work-up/comp bx) |
|
| Test + (Initial MRI BI-RAD 0, 4, 5) |
|
| Test + (Initial MRI BI-RAD 0, 3, 4, 5) |
|
| Test + (Initial MRI BI-RAD 0, 3, 4, 5/work-up)". |
|
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 |
| Binomial Proportion |
| 0.031 |
| Standard Error of the Mean |
| 0.006 |
| 2-Sided |
| 95 |
| 0.021 |
| 0.044 |
| Other |
| 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 | Binomial Proportion | 0.031 | Standard Error of the Mean | 0.006 | 2-Sided | 95 | 0.020 | 0.042 | Other |
| 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 | Binomial proportion | 0.031 | Standard Error of the Mean | 0.006 | 2-Sided | 95 | 0.020 | 0.042 | Other |
| 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 | Binomial Proportion | 0.032 | Standard Error of the Mean | 0.006 | 2-Sided | 95 | 0.021 | 0.043 | Other |
| 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 | Binomial Proportion | 0.032 | Standard Error of the Mean | 0.006 | 2-Sided | 95 | 0.021 | 0.043 | Other |
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.
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|