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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220214
• Other study ID #: SBU-BC-NAC-CEDM
• Secondary ID: IRB2023-00508
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 23, 2024
• Est. completion date: August 2026

Study information

• Verified date: March 2024
• Source: Stony Brook University
• Contact: Alison Stopeck, MD
• Phone: 631-444-7217
• Email: alison.stopeck[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer
• Locally Advanced Breast Cancer
• Neoadjuvant Chemotherapy
• TNBC, Triple Negative Breast Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Diagnostic Test:
• CEDM
Contrast Enhanced Digital Mammography
• 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.

Locations

Country	Name	City	State
United States	Stony Brook Breast Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Alison Stopeck

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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