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

Part of paid clinical trials in Stony Brook, New York.

Sponsor
Alison Stopeck
Study ID
NCT06220214
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CEDM — DIAGNOSTIC_TEST
    Contrast Enhanced Digital Mammography
  • CEDBT — DIAGNOSTIC_TEST
    Contrast-Enhanced Digital Breast Tomosynthesis
  • 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.

Study Details

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.

Key Dates

Start date
Mar 6, 2024
Status verified
Dec 2025
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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)

Primary Outcome Measure

Accuracy of (CEDM+CEDBT) to predict NAC treatment effects [ Time Frame: Immediately after definitive breast surgery, up to 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stony Brook Breast CenterStony BrookNew York11794
Caterina Vacchi-Suzzi, PhD
[email protected]
631-216-2993
Hailiang Huang, PhD
[email protected]
Alison Stopeck, MD (PRINCIPAL_INVESTIGATOR)
Wei Zhao (SUB_INVESTIGATOR)

Find similar trials in Stony Brook, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Stony Brook Breast Center· Stony Brook, NY

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