Intraoperative 3D Imaging for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Clarix Imaging Volumetric Specimen Imager (VSI) for breast cancer?
Research suggests that using advanced imaging techniques like 3D imaging during breast-conserving surgery can help reduce the need for additional surgeries by better identifying cancerous tissue. This is because 3D imaging provides a more detailed view of the tissue, which can help surgeons ensure they have removed all the cancerous cells.12345
How does intraoperative 3D imaging for breast cancer differ from other treatments?
Intraoperative 3D imaging for breast cancer is unique because it uses advanced imaging techniques like x-ray phase contrast tomography to provide high-resolution, three-dimensional images of breast tissue during surgery. This allows for immediate and detailed assessment of tumor margins, potentially reducing the need for additional surgeries, unlike traditional methods that rely on slower histological analysis.13467
What is the purpose of this trial?
This clinical trial assesses if the use of a three-dimensional imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room (intraoperative imaging) for patients with breast cancer and breast ductal carcinoma in situ. Breast conservation surgery or lumpectomy is a standard of care (routine) procedure that removes the tumor and a rim of surrounding normal tissue (margins) while leaving as much normal breast tissue as possible. A margin that does not contain tumor cells is called a negative margin and tells the surgeon that the primary tumor has been removed. A positive margin contains tumor cells at or near the edge of the tissue removed. As part of standard of care, surgeons take two-dimensional x-ray images of the tissue that has been removed in the operating room to assess if there is any additional tissue that should be shaved (removed) to get a negative margin. After the surgery is over, the tissue is examined once again by a pathologist in a laboratory to determine if there are any small pieces of tumor left in the margin that were not visible during surgery. If residual tumor is detected in the margin, a reoperation may be required to remove additional tissue until the tumor has been completely removed from the margin. Diagnostic procedures, such as intraoperative volumetric specimen imaging may reduce the rate of reoperation of for patients who previously underwent lumpectomy.
Research Team
Swati A Kulkarni, MD
Principal Investigator
Northwestern University
Eligibility Criteria
This trial is for women over 18 with invasive breast cancer or ductal carcinoma in situ (DCIS) who are undergoing a lumpectomy. They must have visible lesions on imaging tests and can have received chemotherapy. Women with bilateral/multicentric disease or other malignancies that don't affect the trial's safety/efficacy can join, but not if they need large tissue removal or re-excision.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Imaging
Patients undergo breast conservation surgery and VSI intraoperative imaging is captured on the day of surgery
Follow-up
Participants are monitored for safety and effectiveness after surgery
Treatment Details
Interventions
- Clarix Imaging Volumetric Specimen Imager (VSI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator