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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00778 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 1B-16-3 | 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 pilot clinical trial studies how well contrast enhanced spectral mammography works with digital breast tomosynthesis in imaging patients with newly diagnosed breast cancer. Contrast enhanced spectral mammography uses a special dye that is injected into the veins before mammogram images are taken. Digital breast tomosynthesis uses multiple x-ray pictures to produce a 3-dimensional rendering of the entire breast. Contrast enhanced spectral mammography with digital breast tomosynthesis may highlight areas of concern within the breast in more detail than a standard mammogram and improve the accuracy of tumor size.
PRIMARY OBJECTIVES:
I. To compare the index lesion size (the largest diameter) from each of the four readings (standard of care 2 dimensional [D], magnetic resonance imaging [MRI], contrast enhanced spectral mammography [CESM], 3D) to gold standard index lesion size from surgical pathology (the largest diameter).
II. To document the additional ipsilateral and contralateral breast cancer lesions detected by the MRI, CESM, and 3D readings listed above.
OUTLINE:
Patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent intravenously (IV) and then undergo a CESM with digital breast tomosynthesis (DBT) over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast contrast enhanced (CE)-MRI over 10 minutes.
After completion of study, patients are followed up within 24-96 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (CESM with DBT) | Experimental | Patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent IV and then undergo a CESM with DBT over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast CE-MRI over 10 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast Agent | Other | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Index lesion size using the largest diameter | Intra-class correlation will be used to assess the agreement of index lesion size from each imaging reading to the gold standard (histopathology at surgery). Bland-Altman plot will be used to illustrate the pattern of difference between each reading and the gold standard. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Yamashita, MD | 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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| Digital Tomosynthesis Mammography | Procedure | Undergo CESM with DBT |
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| Dual-Energy Contrast-Enhanced Digital Spectral Mammography | Procedure | Undergo CESM with DBT |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003287 | Contrast Media |
| ID | Term |
|---|---|
| D064907 | Diagnostic Uses of Chemicals |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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