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| ID | Type | Description | Link |
|---|---|---|---|
| IRB2023-00508 | Other Identifier | Stony Brook IRB |
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The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner.
Participation may last up to 18 weeks.
Study procedures for this research are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEDM + CEDBT | Experimental | Participants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEDM | Diagnostic Test | Contrast Enhanced Digital Mammography |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of (CEDM+CEDBT) to predict NAC treatment effects | The ability of CEDM + CEDBT to predict pathologic complete response to neoadjuvant chemotherapy, determined by histopathology evaluation of the resected breast | Immediately after definitive breast surgery, up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of (CEDM+CEDBT) to detect residual tumor compared with standard of care MRI | Concordance between CEDM + CEDBT and standard of care MRI in quantifying residual tumor size | Immediately before definitive breast surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alison Stopeck, MD | Contact | 631-444-7217 | alison.stopeck@stonybrookmedicine.edu | |
| Caterina Vacchi-Suzzi, PhD | Contact | 631-216-2993 | caterina.vacchi-suzzi@stonybrookmedicine.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alison Stopeck, MD | Stony Brook Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook Breast Center | Recruiting | Stony Brook | New York | 11794 | United States |
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| CEDBT |
| Diagnostic Test |
Contrast-Enhanced Digital Breast Tomosynthesis |
|
| Omnipaque 350mgI/mL Solution for Injection | Drug | Injection of an FDA approved iodinated contrast agent is required to undergo the imaging procedures. It is not the intent of the study to evaluate the contrast agent, but it will be administered at the time of experimental imaging. |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative 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 |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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