NCT06220214RecruitingEarly phase 1
Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer
Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 5 Jan 2024
- Start date
- 6 Mar 2024
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Alison Stopeck
- NCT number
- NCT06220214
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 30
- From 6 Mar 2024 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergy/sensitivity to contrast agent
- Diabetes
Other
- Pregnancy
- Decreased kidney function
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stony Brook Breast Center Coordinator of this site? Confirm its status | Stony Brook | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.