RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy

Quick Facts

Study Start:2024-03-06
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06220214

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status
  2. * Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery
  1. * Pregnancy
  2. * Allergy/sensitivity to contrast agent
  3. * Decreased kidney function
  4. * Diabetes

Contacts and Locations

Study Contact

Alison Stopeck, MD
CONTACT
631-444-7217
alison.stopeck@stonybrookmedicine.edu
Caterina Vacchi-Suzzi, PhD
CONTACT
631-216-2993
caterina.vacchi-suzzi@stonybrookmedicine.edu

Principal Investigator

Alison Stopeck, MD
PRINCIPAL_INVESTIGATOR
Stony Brook Cancer Center

Study Locations (Sites)

Stony Brook Breast Center
Stony Brook, New York, 11794
United States

Collaborators and Investigators

Sponsor: Alison Stopeck

  • Alison Stopeck, MD, PRINCIPAL_INVESTIGATOR, Stony Brook Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-06
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2024-03-06
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • cedm
  • cedbt
  • contrast-enhanced digital mammography
  • contrast-enhanced digital breast tomosynthesis
  • neoadjuvant chemotherapy

Additional Relevant MeSH Terms

  • Breast Cancer
  • Locally Advanced Breast Cancer
  • Neoadjuvant Chemotherapy
  • HER2-positive Breast Cancer
  • Triple Negative Breast Cancer
  • TNBC, Triple Negative Breast Cancer