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

NCT ID: NCT06220214

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-06
• Study Completion Date: 2026-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

CEDM

Intervention Type: DIAGNOSTIC_TEST

Contrast Enhanced Digital Mammography

CEDBT

Intervention Type: DIAGNOSTIC_TEST

Contrast-Enhanced Digital Breast Tomosynthesis

Omnipaque 350mgI/mL Solution for Injection

Intervention Type: 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.

Interventions

CEDM

Contrast Enhanced Digital Mammography

Intervention Type: DIAGNOSTIC_TEST

CEDBT

Contrast-Enhanced Digital Breast Tomosynthesis

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alison Stopeck

OTHER

Sponsor Role: lead

Responsible Party

Alison Stopeck

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alison Stopeck, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook Cancer Center

Locations

Stony Brook Breast Center

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alison Stopeck, MD

Role: CONTACT

alison.stopeck@stonybrookmedicine.edu

631-444-7217

Caterina Vacchi-Suzzi, PhD

Role: CONTACT

caterina.vacchi-suzzi@stonybrookmedicine.edu

631-216-2993

Facility Contacts

Caterina Vacchi-Suzzi, PhD

Role: primary

caterina.vacchi-suzzi@stonybrookmedicine.edu

631-216-2993

Hailiang Huang, PhD

Role: backup

Hailiang.Huang@stonybrookmedicine.edu

Other Identifiers

IRB2023-00508

Identifier Type: OTHER

Identifier Source: secondary_id

SBU-BC-NAC-CEDM

Identifier Type: -

Identifier Source: org_study_id