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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Stony Brook Breast Center
Coordinator of this site? Confirm its status
Stony BrookUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.