Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03686215
Phase: Phase III
Principal Investigator: Lee, Marie
Pivotal Study of the Lum Imaging System For Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patient with Breast Cancer
This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients undergoing breast surgery in order to assist surgeons in reducing the rates of positive margins
The objective of this prospective, multi-center, two-arm randomized, blinded study is to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients. Up to 170 patients will be enrolled in this study.
Therapy (NOS)
LUM015 ()
Inclusion Criteria:
Exclusion Criteria:
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