Intraoperative 3D Imaging for Breast Cancer

Recruiting at 3 trial locations

Overseen by Swati A Kulkarni, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Prior Safety Data

Trial Summary

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

I have had chemotherapy before surgery for breast cancer.

I have breast cancer and will have surgery to remove part of my breast.

I have been diagnosed with a type of breast cancer.

Exclusion Criteria

My lumpectomy specimen is expected to be smaller than 9x9x7 cm.

I am not having a re-excision for breast cancer.

Note: The specimen size limitation for the VSI device is 9 cm x 9 cm x 7 cm (length x width x height)

Treatment Details

Interventions

• Clarix Imaging Volumetric Specimen Imager (VSI) (Imaging Device)

Trial Overview The study is testing a new three-dimensional imaging device called Clarix Imaging VSI during surgery to see if it helps surgeons remove all cancerous tissue more effectively than current two-dimensional x-ray methods, potentially reducing the need for additional surgeries.

Participant Groups

Group I: Diagnostic (Volumetric Specimen Imager Device) Experimental Treatment 2 Interventions

Patients undergo breast conservation surgery (lumpectomy or partial mastectomy) per standard care, and VSI intraoperative imaging is captured on the day of surgery.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+