Contrast-Enhanced Mammography for Breast Cancer
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves imaging and contrast agents, it's best to discuss your medications with the research team to ensure there are no interactions.
What data supports the effectiveness of the drug Omnipaque 350mgI/mL Solution for Injection, Iohexol, Omnipaque 350?
Is Omnipaque (Iohexol) generally safe for use in humans?
Omnipaque (Iohexol) is generally well-tolerated in humans, with fewer side effects compared to some other contrast media. However, it can cause minor skin reactions and, in rare cases, changes in neurological status or minor heart rate changes. In animal studies, it was found to be more irritating to the lungs than previously thought.23678
How does contrast-enhanced mammography differ from other breast cancer treatments?
Contrast-enhanced mammography (CEM) is unique because it uses an iodine-containing contrast medium to improve the visibility of breast tumors, which is not a feature of standard mammography. This method allows for better detection and characterization of lesions by producing enhanced images through a combination of low and high energy exposures.910111213
What is the purpose of this trial?
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.
Research Team
Alison Stopeck, MD
Principal Investigator
Stony Brook Cancer Center
Eligibility Criteria
This trial is for individuals with early-stage, invasive breast cancer who are planning to undergo at least four cycles of neoadjuvant chemotherapy before surgery. Participants will have mammograms using a contrast agent during/after chemo but before surgery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy
Participants receive neoadjuvant chemotherapy, with imaging occurring after every 4-6 cycles
Imaging and Surgery Preparation
Participants undergo CEDM + CEDBT imaging and prepare for definitive breast surgery
Follow-up
Participants are monitored for safety and effectiveness after surgery
Treatment Details
Interventions
- Omnipaque 350mgI/mL Solution for Injection
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Who Is Running the Clinical Trial?
Alison Stopeck
Lead Sponsor