This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.
Detailed Description: All subjects will be injected with LUM015. The injection of the study drug will occur 2-6 hours prior to surgery at a dose of 1.0 mg/kg. For all subjects, surgeons will perform main specimen resection per standard of care. For subjects randomized to the intervention arm, the surgeon will use the Lum System to scan and image all orientations within the cavity and The LUM Imaging System will guide shave removal. Then, for all subjects (control and intervention arm), comprehensive shaved margins are removed. In this study, the initial cohort is a "training set" with 10 patients receiving neoadjuvant therapy to refine the tumor detection algorithm, if needed. After completion of enrollment of the initial 10 subjects for algorithm training, the Investigators will then enroll a cohort of patients who received neoadjuvant therapy to further evaluate the performance of the LUM Imaging System in this important subset of breast cancer patients. Concurrently to the enrollment of this cohort, surgeons will also enroll a cohort of patients who did not receive neoadjuvant therapy prior to surgery. Patients will be randomized 3:1 to a LUM-assisted lumpectomy versus a standard lumpectomy. In both arms, shaved margins will be taken from the entire lumpectomy cavity to compare the extent of residual tumor after standard and LUM-assisted lumpectomies to evaluate the negative predictive value of the LUM Imaging System following neoadjuvant therapy. Only the group of patients randomized to the device (intervention) arm will have the LUM Imaging System guide the removal of tissue prior to the removal of final comprehensive shaves of the entire cavity. Study treatment ends when the surgery is completed. Patients are followed for adverse events until their standard of care follow-up visit or after any secondary surgery, whichever is longer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
98
LUM015 will be administered 2 to 6 hours prior to surgery for both arms. The LUM Imaging device will be used to assist in the removal of additional tumor tissue in the device intervention arm.
UM015 will be administered 2 to 6 hours prior to surgery for both arms. The LUM Imaging device will be used to assist in the removal of additional tumor tissue in the device intervention arm.
Stanford Hospital and Clinics
Palo Alto, California, United States
Morton Plant Mease Health Care Oncology Research
Clearwater, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Duke Cancer Center
Durham, North Carolina, United States
Development and validation of tumor detection algorithms in breast cancer patients receiving neoadjuvant therapy
Refining of the previously validated tumor detection algorithm in breast cancer patients receiving neoadjuvant therapy will be conducted in the first cohort and the validation of this algorithm will use data from the second cohort.
Time frame: 1 month
Number of patients with reported adverse events
Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
Time frame: 14 days
Reduction in residual tumor
Evaluate reduction in residual tumor left after Lumicell assisted lumpectomy compared with SoC removal of main lumpectomy specimen in patients who have received and not received neo-adjuvant therapy
Time frame: 3 months
Report on patient reported outcomes and patient preference information
Collect and summarize patient reported information on outcomes and preference
Time frame: 12 months
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Novant Health Cancer Center
Winston-Salem, North Carolina, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States