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Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer
Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy
Who can join
Ages 18 and older · Women
Full eligibility criteria
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
About the study
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.
What is being tested
- CEDM (diagnostic test)
- CEDBT (diagnostic test)
- Omnipaque 350mgI/mL Solution for Injection (drug)
Sponsor: Alison Stopeck · Participants: 30 · Started: Mar 6, 2024
Contact the study team
- Alison Stopeck, MD · Phone: 631-444-7217
- Caterina Vacchi-Suzzi, PhD · Phone: 631-216-2993
Official record on ClinicalTrials.gov — NCT06220214
Locations in the U.S.
| New York | Stony Brook Breast Center, Stony Brook |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.