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Intraoperative Detection of Residual Cancer in Breast Cancer

NCT03321929 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2023-05-01

Study results available
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Summary

This is a non-randomized, open-label, multi-site study to collect safety and efficacy data on an intraoperative imaging system, the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM imaging device), in identifying residual cancer in the tumor bed of female breast cancer patients. During the study, study physicians and clinical staff will complete hands-on training in anticipation of the upcoming pivotal study. Site-specific or user-specific issues related to the use of the device will be identified and addressed. Additionally, the data collected in the study will be used to continue training the tumor detection algorithm of the device.

In this study, patients will be injected with LUM015 prior to surgery. The study physicians will perform lumpectomy procedures according to his or her institution's standard of care practice. After the main specimen removal is completed, the study physician will use the LUM Imaging Device to image the tumor bed. Therapeutic shaves will be removed based on the recommendation of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.

Conditions

Interventions

COMBINATION_PRODUCT

LUM Imaging System

Drug: LUM015 Device: LUM 2.6 Imaging Device

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Lumicell, Inc.

    lead INDUSTRY

Principal Investigators

  • Barbara Smith, M.D., Ph.D. · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2020-04-10
Completion
2020-04-10
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03321929 on ClinicalTrials.gov