Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer

Last updated: September 4, 2024
Sponsor: Alison Stopeck
Overall Status: Active - Recruiting

Phase

1

Condition

Breast Cancer

Chemotherapy

Cancer

Treatment

Omnipaque 350mgI/mL Solution for Injection

CDBT

CEDM

Clinical Study ID

NCT06220214
SBU-BC-NAC-CEDM
IRB2023-00508
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis with either type of invasive locally advanced breast cancer regardless ofhormone receptor or Her2 status

  • Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitivesurgery

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Allergy/sensitivity to contrast agent

  • Decreased kidney function

  • Diabetes

Study Design

Total Participants: 30
Treatment Group(s): 4
Primary Treatment: Omnipaque 350mgI/mL Solution for Injection
Phase: 1
Study Start date:
March 06, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Stony Brook Breast Center

    Stony Brook, New York 11794
    United States

    Active - Recruiting

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