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

Alison Stopeck

Status and phase: Enrolling; Early Phase 1

Conditions: Breast Cancer; Locally Advanced Breast Cancer; Neoadjuvant Chemotherapy; HER2-positive Breast Cancer; Triple Negative Breast Cancer; TNBC, Triple Negative Breast Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06220214

SBU-BC-NAC-CEDM

IRB2023-00508 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

CEDM + CEDBT

Experimental group

Description:

Participants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times)

Treatment:

Drug: Omnipaque 350mgI/mL Solution for Injection

Diagnostic Test: CEDBT

Diagnostic Test: CEDM