Lumicell in Breast Cancer Patients - Clinical Trial

What is the Purpose of this Study?

We are doing this study to test how well the Lumicell system works in finding cancer cells in patients who are having lumpectomy for breast cancer.

What is the Condition Being Studied?

Breast Cancer

Who Can Participate in the Study?

Adults with breast cancer who:
- Are receiving chemotherapy; OR
- Are not receiving chemotherapy
- Are scheduled to get a lumpectomy at Duke

For more information about who can join this study, please contact the study team at kimberly.turnage@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Get an injection of a study drug before your lumpectomy (LUM015 - this is a dye being developed to locate cancer cells)
- Be randomly assigned (like a coin flip) to have the normal lumpectomy surgery done or to have the surgery assisted by the Lumicell handheld device that scans the cavity in your breast during lumpectomy
- Have blood draws

We will schedule you for a follow-up visit after your lumpectomy. We will also call you at approximately 3, 6 and 12 months after the surgery to see how you are doing.

Study Details

Full Title
FEASIBILITY STUDY TO EVALUATE PERFORMANCE OF THE LUM IMAGING SYSTEM FOR INTRAOPERATIVE DETECTION OF RESIDUAL TUMOR IN BREAST CANCER PATIENTS RECEIVING AND NOT RECEIVING NEOADJUVANT THERAPY
Principal Investigator
Surgical Oncologist
Protocol Number
IRB: PRO00107018
NCT: NCT04440982
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698