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Feasibility Study of Intraoperative Imaging in Breast Cancer

NCT02438358 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-01-05

Study results available
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Summary

For most breast cancer patients, surgery is the primary treatment. When patients undergo a lumpectomy, it is difficult for the surgeon to determine the extent of the tumor which results in incomplete tumor removal as determined by a positive margin assessment several days after the initial surgery is completed. Most patients with positive margins will undergo a second or even a third surgery to complete the tumor removal. The investigators hypothesize that the LUM Imaging System can reduce the rates of positive margins and, thus, the rates of second surgeries by identifying microscopic residual cancer in the tumor bed.

This is a non-randomized, open label study to evaluate the safety and efficacy of an intraoperative imaging system, the LUM Imaging System (LUM015 in conjunction with LUM 2.6 Imaging Device), in identifying residual cancer in the tumor bed of female breast cancer subjects. The study is composed of a Feasibility Trial divided into two phases: Phase A (15 total subjects) and Phase B (up to 50 total subjects). During Phase A, 15 subjects will be evaluated to collect additional patient safety data, select the dose of LUM015 for Phase B and evaluate the device function. During Phase B, subjects will be injected with LUM015 at the dose determined during Phase A to preliminarily assess the performance of the detection algorithm against pathology margin assessment. In Phase B, the surgeon will perform standard of care surgery and then use the LUM Imaging System to guide the removal of additional cavity shavings as indicated by the LUM Imaging System.

Conditions

Interventions

DRUG

LUM015

DEVICE

LUM 2.6 Imaging Device

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Massachusetts General Hospital

    collaborator OTHER

  • Dana-Farber Cancer Institute

    collaborator OTHER

  • Lumicell, Inc.

    lead INDUSTRY

Principal Investigators

  • Barbara L 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
2015-06-30
Primary Completion
2017-09-30
Completion
2017-10-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02438358 on ClinicalTrials.gov