Breast Cancer, HER2-positive Breast Cancer, Locally Advanced Breast Cancer, Neoadjuvant Chemotherapy, TNBC, Triple Negative Breast Cancer, Triple Negative Breast Cancer
Conditions
Keywords
cedm, cedbt, contrast-enhanced digital mammography, contrast-enhanced digital breast tomosynthesis, neoadjuvant chemotherapy
Brief summary
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: * Undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery. * Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent * Let the research team record information from your medical record related to your condition and the treatment you receive. * Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.
Interventions
DIAGNOSTIC_TESTCEDM
Contrast Enhanced Digital Mammography
DIAGNOSTIC_TESTCEDBT
Contrast-Enhanced Digital Breast Tomosynthesis
DRUGOmnipaque 350mgI/mL Solution for Injection
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.
Sponsors
Alison Stopeck
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status * Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery
Exclusion criteria
* Pregnancy * Allergy/sensitivity to contrast agent * Decreased kidney function * Diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of (CEDM+CEDBT) to predict NAC treatment effects | Immediately after definitive breast surgery, up to 24 weeks | The ability of CEDM + CEDBT to predict pathologic complete response to neoadjuvant chemotherapy, determined by histopathology evaluation of the resected breast |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of (CEDM+CEDBT) to detect residual tumor compared with standard of care MRI | Immediately before definitive breast surgery | Concordance between CEDM + CEDBT and standard of care MRI in quantifying residual tumor size |
Countries
United States
Contacts
Primary ContactAlison Stopeck, MD
Backup ContactCaterina Vacchi-Suzzi, PhD
Outcome results
None listed