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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01365 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 1B-05-5 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies mammography and targeted ultrasound with or without whole-breast ultrasound or contrast-enhanced magnetic resonance imaging (MRI) in finding out the extent of disease before surgery in patients with newly diagnosed breast cancer. New diagnostic imaging procedures, such as whole-breast ultrasound or contrast-enhanced MRI, may help find out how far breast cancer has spread. It is not yet known whether mammography and targeted ultrasound are more effective with or without whole-breast ultrasound or contrast-enhanced MRI in finding out how far breast cancer has spread.
PRIMARY OBJECTIVES:
I. To determine how surgical treatment is influenced by the three imaging arms.
II. To compare three imaging arms in terms of accurately measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as gold standard).
SECONDARY OBJECTIVES:
I. In women with dense breasts: To retrospectively compare the accuracy of three imaging arms in measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as the gold standard).
II. To report the incidence of synchronous contralateral breast cancers detected by the three imaging arms.
OUTLINE: Patients are assigned to 1 of 3 treatment groups.
GROUP 1: Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound.
GROUP 2: Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound.
GROUP 3: Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI.
All patients undergo standard of care breast conserving surgery, or mastectomy if the tests indicate a change in the surgical plan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (standard of care) | Active Comparator | Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound. |
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| Group 2 (bilateral whole-breast ultrasound) | Experimental | Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound. |
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| Group 3 (bilateral breast contrast-enhanced MRI) | Experimental | Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-enhanced Magnetic Resonance Imaging | Procedure | Undergo bilateral breast contrast enhanced MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference between the longest diameter of the index lesion as determined by imaging versus as determined by the pathologist | Every attempt will be made to identify a transformation for the difference in the lengths of the largest diameters. If none are found, then the data will be summarized with histograms, medians, quartiles, and ranges. If a transformation is found, means, standard deviations, and 95% confidence intervals will be reported instead of the median and quartiles. Differences between three imaging methods will be compared using a paired t-test (or paired rank sum test). | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients identified with invasive breast cancer in women who have dense or no dense breasts as determined by the 3 imaging arms | The analyses above will be rerun, stratifying by breast density: the differences in the modalities will be estimated for women with dense breasts and without, and the differences between the two groups of women will also be estimated. Dense will be defined as dense parenchyma involving more than 50% of breast volume. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Hovanessian-Larsen | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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| Mammography | Procedure | Undergo bilateral mammography |
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| Therapeutic Conventional Surgery | Procedure | Undergo breast conserving surgery |
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| Ultrasonography | Procedure | Undergo bilateral whole-breast ultrasound |
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| Ultrasonography | Procedure | Undergo targeted breast ultrasound |
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| Gadolinium | Other | Contrast agent used in MRI |
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| Up to 4 weeks |
| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| D005682 | Gadolinium |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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