Clinical trial NCT06220214: Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer
Official title: Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Locally Advanced Breast Cancer
Neoadjuvant Chemotherapy
HER2-positive Breast Cancer
Triple Negative Breast Cancer
TNBC, Triple Negative Breast Cancer
Keywords: cedm
cedbt
contrast-enhanced digital mammography
contrast-enhanced digital breast tomosynthesis
neoadjuvant chemotherapy
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 Criteria:

* 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

Exclusion Criteria:

* Pregnancy
* Allergy/sensitivity to contrast agent
* Decreased kidney function
* Diabetes

Primary outcomes:
measure: Accuracy of (CEDM+CEDBT) to predict NAC treatment effects
timeFrame: Immediately after definitive breast surgery, up to 24 weeks
Secondary outcomes:
measure: Accuracy of (CEDM+CEDBT) to detect residual tumor compared with standard of care MRI
timeFrame: Immediately before definitive breast surgery
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook Breast Center
state: New York
Study officials:
affiliation: Stony Brook Cancer Center
name: Alison Stopeck, MD
role: PRINCIPAL_INVESTIGATOR
References: