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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Stony Brook Breast Center
RECRUITING
Stony Brook
Contact Information
Primary
Alison Stopeck, MD
alison.stopeck@stonybrookmedicine.edu
631-444-7217
Backup
Caterina Vacchi-Suzzi, PhD
caterina.vacchi-suzzi@stonybrookmedicine.edu
631-216-2993
Time Frame
Start Date: 2024-03-06
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 30
Treatments
Experimental: CEDM + CEDBT
Participants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times)
Related Therapeutic Areas
Sponsors
Leads: Alison Stopeck

This content was sourced from clinicaltrials.gov