Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CEDM, CEDBT, Omnipaque 350mgI/mL Solution for Injection.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Locally Advanced Breast Cancer, Neoadjuvant Chemotherapy, HER2-positive Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy
Overview
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 test CEDM
Contrast Enhanced Digital Mammography - Diagnostic test CEDBT
Contrast-Enhanced Digital Breast Tomosynthesis - Drug Omnipaque 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.
Primary outcome measures
- Accuracy of (CEDM+CEDBT) to predict NAC treatment effects [Time frame: Immediately after definitive breast surgery, up to 24 weeks]
Secondary outcome measures (1)
- Accuracy of (CEDM+CEDBT) to detect residual tumor compared with standard of care MRI [Time frame: Immediately before definitive breast surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Stony Brook Breast Center — Stony Brook
Identifiers
NCT: NCT06220214 · SBU-BC-NAC-CEDM · IRB2023-00508