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Clinical Trial 20499

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03686215

Phase: Phase III
Principal Investigator: Lee, Marie

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

Pivotal Study of the Lum Imaging System For Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patient with Breast Cancer

Summary

This is a multi-center, two-arm randomized, blinded pivotal study 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 undergoing breast surgery in order to assist surgeons in reducing the rates of positive margins

Objective

The objective of this prospective, multi-center, two-arm randomized, blinded 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. Up to 170 patients will be enrolled in this study.

Treatments

Therapies

Therapy (NOS)

Medications

LUM015 ()

Inclusion Criteria

Inclusion Criteria:

Participants must have histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or primary invasive breast cancer with a DCIS component.

Female, age of 18 years or older.

Participants must be scheduled for a lumpectomy for a breast malignancy.

Participants must be able and willing to follow study procedures and instructions.

Participants must have received and signed an informed consent form.

Participants must have no uncontrolled serious medical problems except for the diagnosis of breast cancer, as per the exclusion criteria listed below.

Participants must have organ and marrow function within limits as defined in the protocol.

Participants with ECOG performance status of 0 or 1.

Exclusion Criteria

Exclusion Criteria:

Participants who have been diagnosed with bilateral breast cancer and are undergoing bilateral resection procedure

Participants who are pregnant. Breastfeeding should be discontinues if the mothers is treated with LUM015

Participants who are sexually active and not willing/able to use 2 medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015.

Participants who have taken an investigational drug within 30 days of enrollment.

Participants 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.

Participants who have not recovered from adverse events due to other pharmaceutical or diagnostic agents.

Participants with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those participants with known HTN should be stable with controlled HTN while under pharmaceutical therapy.

History of allergic reaction to polyethylene glycol (PEG).

History of allergic reaction to any oral or intravenous contrast agents.

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.

HIV-positive individuals on combination antiretroviral therapy are ineligible.

Any participant for whom the investigator feels participation is not in the best interest of the participant.

Participants undergoing a second lumpectomy procedure because of positive margins in a previous surgery prior to entering this study

Participants with post-biopsy hematomas greater or equal to 2 cm that are visible on physical exam or detected during pre-operative observations.

Participants with prior ipsilateral breast cancer surgeries, mastectomies, breast reconstructions or implants.s with prior ipsilateral breast cancer surgeries, mastectomies, breast reconstructions or implants

Participants with prior ipsilateral reduction mammoplasties (breast reductions) performed less than 2 years prior to enrollment to this study.

Participants previously treated with systemic therapies to treat the cancer to be removed during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal therapy.

Participants undergoing breast conserving surgery whose resected speciment (main lump, shaves, or any other resected tissue) will be evaluated with frozen section after the Lumicell-guided removal of shaves.

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