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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Triple Negative Breast Cancer; HER2-positive Breast Cancer; TNBC, Triple Negative Breast Cancer; Locally Advanced Breast Cancer; Neoadjuvant Chemotherapy
• Intervention / Treatment: Diagnostic test: CEDM; Diagnostic test: CEDBT; Drug: Omnipaque 350mgI/mL Solution for Injection

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Caterina Vacchi-Suzzi, PhD; Phone Number: 631-216-2993; Email: caterina.vacchi-suzzi@stonybrookmedicine.edu
• Study Contact Backup: Name: Alison Stopeck, MD; Phone Number: 631-444-7217; Email: alison.stopeck@stonybrookmedicine.edu

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook Breast Center
      • Sub-Investigator: Wei Zhao
      • Contact: Caterina Vacchi-Suzzi, PhD; Phone Number: 631-216-2993; Email: caterina.vacchi-suzzi@stonybrookmedicine.edu
      • Principal Investigator: Alison Stopeck, MD
      • Contact: Hailiang Huang, PhD; Email: Hailiang.Huang@stonybrookmedicine.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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)

Diagnostic test: CEDM; Contrast Enhanced Digital Mammography; Diagnostic test: CEDBT; Contrast-Enhanced Digital Breast Tomosynthesis; Drug: Omnipaque 350mgI/mL Solution for Injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of (CEDM+CEDBT) to predict NAC treatment effects	The ability of CEDM + CEDBT to predict pathologic complete response to neoadjuvant chemotherapy, determined by histopathology evaluation of the resected breast	Immediately after definitive breast surgery, up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of (CEDM+CEDBT) to detect residual tumor compared with standard of care MRI	Concordance between CEDM + CEDBT and standard of care MRI in quantifying residual tumor size	Immediately before definitive breast surgery

Collaborators and Investigators

• Sponsor: Alison Stopeck
• Investigators: Principal Investigator: Alison Stopeck, MD, Stony Brook Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 23, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: neoadjuvant chemotherapy; cedm; cedbt; contrast-enhanced digital mammography; contrast-enhanced digital breast tomosynthesis
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: SBU-BC-NAC-CEDM; IRB2023-00508 (Other Identifier: Stony Brook IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No