Breast Cancer Clinical Trial
Official title:
Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer
This is a multi-center, single-arm 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 in order to assist surgeons in reducing the rates of
positive margins.
In this study, patients will be injected with LUM015 prior to surgery. The study physician
should perform their standard of care lumpectomy, which may include the removal of shaves.
Therapeutic (Lumicell guided) shaves will be removed based on the recommendation of the LUM
Imaging System after the standard of care lumpectomy. Patients will be followed until their
first standard of care post-operative follow-up visit.
For breast cancer lumpectomies, the presence of residual cancer cells left in the tumor bed
after initial resection is inferred by post-operative margin assessment of the resected
tissue by a pathologist.
The injection of the study drug will occur 2-6 hours prior to surgery at a dose of 1.0 mg/kg.
The surgeon will complete the lumpectomy and remove any standard of care shaves if
applicable. The surgeon will use the Lumicell device to look inside the lumpectomy cavity to
see if the dye indicates any areas that may contain residual tumor. If the imaging identifies
that there may be cancer cells remaining in the lumpectomy cavity, the surgeon will remove an
additional piece of tissue. This process will be continued until a negative reading from the
device is obtained or a maximum of 2 shaves of additional tissue has been removed in each
orientation.
Study treatment ends when the surgery is completed. All patients will continue their
enrollment in the study until their first follow-up visit and they will continue to be
followed until the medical team determines no further surgical intervention is required.
Patients with adverse events that are determined to be possibly related to the LUM Imaging
System will be followed until resolution or stabilization of the adverse event.
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