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

NCT04440982 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-01-15

No results posted yet for this study

Summary

This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Lumicell, Inc.

    lead INDUSTRY

Principal Investigators

  • Barbara Smith, MD, PhD · Massachusetts General Hospital

  • Jorge Ferrer, PhD · Lumicell, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-11-30
Completion
2024-02-29
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 NCT04440982 on ClinicalTrials.gov