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Brief Title: Feasibility Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients
Official 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
Study ID: NCT04440982
Brief Summary: This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Novant Health Cancer Center, Winston-Salem, North Carolina, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Name: Barbara Smith, MD, PhD
Affiliation: Massachusetts General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jorge Ferrer, PhD
Affiliation: Lumicell, Inc.
Role: STUDY_DIRECTOR