The purpose of the Lumicell Imaging System is to enable surgeons to achieve negative margins during the initial surgery and eliminate or reduce the need for re-excision surgeries when compared with current standard of care procedures. Lumicell’s system images the entire lumpectomy cavity surface in vivo, overcoming tissue handling and sampling limitations of standard pathology analysis of resected tissue. The LUM Imaging System provides real-time feedback to the surgeon about the status of the lumpectomy cavity walls.
The objective of this prospective, multi-center, single-arm study is to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients in order to assist surgeons in reducing the rates of positive margins.
Pre- Enrollment /Screening
Day 1 / Enrollment
~2-14 days after surgery
Routine follow up visit
3-month PRO survey collection
Baptist MD Anderson Cancer Center
Subjects must meet the following criteria on screening examination to be eligible to participate in the study:
6.1.1 Subjects must have histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or primary invasive breast cancer with a DCIS component. The methods for obtaining the histological samples can include core needle biopsies or fine needle biopsies. Subjects who had diagnostic open surgical biopsies are excluded from participation.
6.1.2 Female, age of 18 years or older. Because no dosing or adverse event data are currently available on the use of LUM015 in subjects <18 years of age, children are excluded from this study.
6.1.3 Subjects must be scheduled for a lumpectomy for a breast malignancy.
6.1.4 Subjects must be able and willing to follow study procedures and instructions.
6.1.5 Subjects must have received and signed an informed consent form.
6.1.6 Subjects must have no uncontrolled serious medical problems except for the diagnosis of breast cancer, as per the exclusion criteria listed below.
6.2 Exclusion Criteria
Subjects who exhibit any of the following conditions at screening will not be eligible for admission into the study.
6.2.1 Subjects who have been diagnosed with bilateral breast cancer and are undergoing a bilateral resection procedure.
6.2.2 Subjects who are pregnant at the time of diagnosis of their breast cancer; this exclusion is necessary because the teratogenic properties of LUM015 are unknown. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with LUM015, breastfeeding should be discontinued if the mother is treated with LUM015.
6.2.3 Subjects who are sexually active and not willing/able to use 2 medically acceptable forms of contraception (hormonal, barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Breast cancer patients are routinely advised against becoming pregnant during treatment, so this requirement does not differ from standard of care.
6.2.4 Subjects who have taken an investigational drug within 30 days of enrollment.
6.2.5 Subjects who will have administration of methylene blue or any dye for sentinel lymph node mapping on the day of the surgery prior to imaging the lumpectomy cavity with the LUM Imaging Device.
6.2.6 Subjects who have not recovered from adverse events due to other pharmaceutical or diagnostic agents.
6.2.7 Subjects with uncontrolled hypertension defined as persistent systolic blood pressure >110 mm Hg; those subjects with known HTN should be stable with controlled HTN while under pharmaceutical therapy.
6.2.8 History of allergic reaction to polyethylene glycol (PEG).
6.2.9 History of allergic reaction to any oral or intravenous contrast agents.
6.2.10 Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements.
6.2.11 HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with LUM015.
6.2.12 Any subject for whom the investigator feels participation is not in the best interest of the subject.
6.2.13 Subjects undergoing a second lumpectomy procedure because of positive margins in a previous surgery prior to entering this study.
6.2.14 Subjects with post-biopsy hematomas greater or equal to 2 cm that are visible on physical exam or detected during pre-operative observations.