# A prospective, multi-center pivotal study of the LUM Imaging System for real-time, in vivo margin assessment in breast conserving surgery

> **NIH NIH R01** · MASSACHUSETTS GENERAL HOSPITAL · 2021 · $274,299

## Abstract

Project Summary/Abstract
Current pre-operative and intraoperative margin assessment techniques fail to adequately guide breast cancer
surgeons to remove all cancer during breast conserving surgeries. As a result, 20-40% of lumpectomy patients
have unrecognized tumor left in the tumor bed during the initial surgery. This residual tumor is only discovered
when the pathologist evaluates the resection margins after surgery and finds a positive margin. The majority of
patients with positive margins (~87%) require a second surgery, which increases health care costs along with
patient anxiety and discomfort. To address this unmet need, Lumicell has developed an intraoperative imaging
system consisting of a molecular imaging agent (LUM015) that emits fluorescence after activation by cancer
associated enzymes, a compact hand-held imaging head (LUM 2.6 Device) that captures the fluorescence
emission of the agent and software that detects and displays invasive carcinomas (80% of the breast cancer
cases) in real-time to guide the surgeon. We, at the Massachusetts General Hospital, are conducting a
feasibility study in breast cancer patients under an FDA-approved IDE. The first part of the feasibility study has
been completed with no adverse events observed in 15 patients. Initial results from the feasibility study show
no false negatives (100% sensitivity) with ~10% false positives. During this study, an approach for detecting
the much smaller foci of ductal carcinoma in situ (DCIS; 20% of breast cancer cases) was developed. As the
first aim of this proposal, the team will develop and implement software for real-time detection of DCIS. The
second aim is a two arm, multi-institution pivotal clinical trial in support of our PMA application to measure the
efficacy of the LUM Imaging System. The primary endpoint of the study is the reduction in positive margin rates
for surgeries in which the LUM Imaging System is used versus standard of care (SOC) treatment for breast
cancer patients undergoing breast conserving lumpectomies. The secondary endpoint is a reduction in the rate
of second surgeries for positive margins when the LUM Imaging System is used. The two arms of the study will
consist of a control arm and a device arm. The control arm will include 100 patients, while the device arm will
include 300 patients. In the control arm, patients will undergo a routine lumpectomy procedure. In the device
arm, patients will undergo a routine lumpectomy procedure followed by imaging of the lumpectomy cavity with
the LUM Imaging System. Additional therapeutic cavity shaves will be removed from regions that LUM
Imaging System determines to contain cancer.

## Key facts

- **NIH application ID:** 9567112
- **Project number:** 5R01CA212138-02
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Jorge Ferrer
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $274,299
- **Award type:** 5
- **Project period:** 2017-09-18 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9567112

## Citation

> US National Institutes of Health, RePORTER application 9567112, A prospective, multi-center pivotal study of the LUM Imaging System for real-time, in vivo margin assessment in breast conserving surgery (5R01CA212138-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9567112. Licensed CC0.

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