Approximately 230,000 women are diagnosed with invasive breast cancer and 60,000 women are diagnosed with ductal carcinoma in situ (DCIS) (breast cancer in the breast milk ducts) annually in the US. Most women choose to be treated with breast conserving surgery (BCS). The goal of BCS is to resect the tumor with a surrounding margin of tissue free of cancer, and to minimize the volume of tissue removed, thereby preserving the overall shape and appearance of the breast. The Standard of Care (SoC) technique for such patients is wire localization, in which a wire is pre-operatively placed near the tumor under mammographic, ultrasonic, or MRI guidance. Wire localization suffers from several limitations. It adds another procedure prior to surgery, complicating and lengthening the process and complicating scheduling. It can be uncomfortable for the patient. Its biggest limitation is inaccuracy. Wire localization requires the surgeon to estimate the three-dimensional (3D) position of the cancer from two-dimensional (2D) mammography images. As a result, positive margins are common after partial mastectomy for non-palpable cancer and DCIS. The aim of this study is to assess whether a device called the Breast Cancer Locator (BCL) can be used during the time of breast cancer removal surgery, and to assess its efficacy, when compared to the SoC group, as defined by the amount of cancer cells remaining in tissue, while assessing the safety of BCL over a period of 6 weeks post-operation.
1. Female gender.
2. Age > 18 years.
3. Histologic diagnosis of invasive breast cancer or DCIS.
1. Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.
2. Severe claustrophobia.
3. Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy.
Screening Visit: All potential subjects will be screened and the following assessments performed:
- Medical history
- Physical examination
- Concomitant medications
- Vital signs
- Radiological assessment
- Serum creatinine
- Glomerular Filtration Rate (GFR)
- Pregnancy test
Pre-Procedure: You will be randomly assigned to one of 2 study groups (Group A – Wire Localization or Group B – BCL System). All subjects enrolled in the study will undergo a physical exam, will submit a small blood sample and will take a pregnancy test if they are of childbearing potential, will have their vital signs taken prior to surgery, and a review of adverse events (AEs) will be performed.
ONLY for subjects randomized to Group B - BCL System (device):
- Subjects assigned to this group will have an MRI with gadolinium contrast performed at least 10 days prior to surgery. This MRI is very similar to the breast MRI you have already had before participating in this study, except that you will be lying on your back (supine) for the research MRI, rather than lying on your stomach. This MRI will take about 20 minutes.
- Just before the MRI, a technician will put two marks on your breast about 1½ inches from your nipple using semi-permanent ink. These marks will be used to help orient the MRI correctly. After the MRI, the technician will cover the marks with a clear dressing. DO NOT take this dressing off or try to remove the marks. Your surgeon will remove the dressing in the operating room at the time of your surgery.
- The information from this MRI will be used to create the BCL, which is specific to the shape of your breast and the location and shape of the tumor in your breast.
If you are the first subject enrolled in the trial at a site, you may be included in a roll-in phase. If you are included in the roll-in phase, you will not be randomized and will automatically be treated with the BCL System.
Surgery (Index Procedure):
Subjects randomized to Group A – Wire Localization (standard of care):
- Subjects assigned to this group will receive the SoC treatment, which means the study treatment is not experimental. A wire is placed into the tumor in your breast immediately prior to surgery under mammographic, ultrasound, or MRI guidance. The wire is placed while you are awake.
- Once the wire is placed, you will be relocated to the operating room where you will be placed under general Version 1/26/2022 anesthesia and your surgeon will remove your tumor using breast conserving surgery.
Subjects randomized to Group B – BCL System (device):
- Subjects will have pre-surgical, contrast-enhanced supine MRI images available, which will be used to create a BCL individually tailored to each subject, using 3-D printing. Your doctor will perform the breast conserving surgery using the BCL device.
- On the day of surgery, your surgeon will remove the dressing covering the markings that were made on your breast during your MRI. You will then be placed under general anesthesia. Your surgeon will place the BCL form on your breast before surgery.
- Following placement of the BCL on your breast and drawing the outline of your cancer on the skin surface, up to 5 wires may be inserted into your breast using the BCL while you are under anesthesia.
Post-Procedure – Follow-Up Visits: Prior to hospital discharge, you will be examined for complications. Post-operative pain medications will be given as part of routine post-operative care.
The subsequent follow-up visits will take place 2- and 6- weeks post-surgery. At 2 weeks post-surgery, subjects will undergo a physical exam, including vital signs, when possible, and will be assessed for AEs. At 6-weeks post-surgery, subjects will be assessed for AEs via phone call 6 weeks post-surgery. Additionally, a review of each subject’s medical record will be performed following surgery.