NCT04440982

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Lumicell, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	LUM015	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.
DEVICE	Lum Imaging System	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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-11-30
• Completion: 2024-02-29
• First posted: 2020-06-22
• Last updated: 2025-01-15

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study