Stony Brook Breast Center
Stony Brook, New York, 11794, United States
Location status: Recruiting
Location contact
Alison Stopeck, MD
PRINCIPAL_INVESTIGATOR
Caterina Vacchi-Suzzi, PhD
CONTACT
Hailiang Huang, PhD
CONTACT
Wei Zhao
SUB_INVESTIGATOR
NCT Number: NCT06220214
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Early Phase 1
Stony Brook, New York, 11794, United States
Location status: Recruiting
Alison Stopeck, MD
PRINCIPAL_INVESTIGATOR
Caterina Vacchi-Suzzi, PhD
CONTACT
Hailiang Huang, PhD
CONTACT
Wei Zhao
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Contrast Enhanced Digital Mammography
Contrast-Enhanced Digital Breast Tomosynthesis
Injection of an FDA approved iodinated contrast agent is required to undergo the imaging procedures. It is not the intent of the study to evaluate the contrast agent, but it will be administered at the time of experimental imaging.
Time frame: Immediately after definitive breast surgery, up to 24 weeks
The ability of CEDM + CEDBT to predict pathologic complete response to neoadjuvant chemotherapy, determined by histopathology evaluation of the resected breast
Time frame: Immediately before definitive breast surgery
Concordance between CEDM + CEDBT and standard of care MRI in quantifying residual tumor size
Contact information is provided by the study sponsor or research team.
Alison Stopeck, MD
CONTACT
Caterina Vacchi-Suzzi, PhD
CONTACT
Alison Stopeck
Other
Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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