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

NCT06220214 | Recruiting Early Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: SBU-BC-NAC-CEDMIRB2023-00508
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Accuracy of (CEDM+CEDBT) to detect residual tumor compared with standard of care MRI

  Immediately before definitive breast surgery

Study Arms (1)

CEDM + CEDBT

EXPERIMENTAL

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; Diagnostic Test: CEDBT; Drug: Omnipaque 350mgI/mL Solution for Injection

Interventions

CEDM DIAGNOSTIC_TEST

Contrast Enhanced Digital Mammography

CEDM + CEDBT

CEDBT DIAGNOSTIC_TEST

Contrast-Enhanced Digital Breast Tomosynthesis

CEDM + CEDBT

Omnipaque 350mgI/mL Solution for Injection DRUG

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.

CEDM + CEDBT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Alison Stopeck: lead

Study Sites (1)

Stony Brook Breast Center

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Alison Stopeck, MD

  Stony Brook Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Stopeck, MD

CONTACT

631-444-7217; alison.stopeck@stonybrookmedicine.edu

Caterina Vacchi-Suzzi, PhD

CONTACT

631-216-2993; caterina.vacchi-suzzi@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 23, 2024
• Study Start: March 6, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)