Pivotal Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoplasm, Residual

• NCT number: NCT03686215
• Study type: Interventional
• Source: Lumicell, Inc.
• Contact: Felix Geissler, MD, PhD
• Phone: 781-591-8378
• Email: felix@lumicell.com
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2018
• Completion date: June 2019