Investigation of Novel Surgical Imaging for Tumor Excision
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Study Device Arm
Intervention description: LUM015 will be administered 2 to 6 hours prior to surgery. The LUM Imaging device will be used to assist in the removal of additional tumor tissue.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to receive the device intervention. All subjects will receive the study drug.
Masking: Double (Investigator, Outcomes Assessor)
Masking description: Masking will only be applied until the standard of care surgery is complete. At time of randomization, the study arm will be revealed to the study team. The pathologist will be masked to the type of tissue obtained from the patient.
Enrollment: 406.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer surgery; lumpectomy

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.

      All enrolled subjects will be injected with LUM015 prior to surgery. Surgeons are blinded to
      whether a participant will be randomized into the device arm until after the standard of care
      lumpectomy is complete. Participants will then be randomized to receiving the device.
      Therapeutic (LUM guided) shaves will be removed based on the guidance of the LUM Imaging
      System. Patients will be followed until their first standard of care post-operative follow-up
      visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  Female, age of 18 years or older.

          -  Subjects must be scheduled for a lumpectomy for a breast malignancy.

          -  Subjects must be able and willing to follow study procedures and instructions.

          -  Subjects must have received and signed an informed consent form.

          -  Subjects must have no uncontrolled serious medical problems except for the diagnosis
             of breast cancer, as per the exclusion criteria listed below.

          -  Subjects must have organ and marrow function within limits as defined below:

               -  Leukocytes > 3,000/microlitre (mcL).

               -  Platelets > 75,000/mcL

               -  total bilirubin within normal institutional limits

               -  Aspartate aminotransferase (AST (SGOT))/alanine transaminase (ALT (SGPT)) < 2.5 X
                  institutional upper limit of normal

               -  Creatinine ≤ 1.5 mg/dL or creatinine clearance > 60 mL/min/1.73 m2 for subjects
                  with creatinine levels above institutional normal.

          -  Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

        Exclusion Criteria:

          -  Subjects who have been diagnosed with bilateral breast cancer and are undergoing
             bilateral resection procedure

          -  Subjects who are pregnant. Breastfeeding should be discontinued if the mothers is
             treated with Pegulicianine (LUM015)

          -  Subjects 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.

          -  Subjects who have taken an investigational drug within 30 days of enrollment.

          -  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.

          -  Subjects who have not recovered from adverse events due to other pharmaceutical or
             diagnostic agents.

          -  Subjects with uncontrolled hypertension defined as persistent systolic blood pressure
             > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those subjects with known
             hypertension (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, chronic obstructive pulmonary disease (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 subject for whom the investigator feels participation is not in the best interest
             of the subject.

          -  Subjects undergoing a second lumpectomy procedure because of positive margins in a
             previous surgery prior to entering this study

          -  Subjects with post-biopsy hematomas greater or equal to 2 cm that are visible on
             physical exam or detected during pre-operative observations.

          -  Subjects with prior ipsilateral breast cancer surgeries, mastectomies, breast
             reconstructions or implants.s with prior ipsilateral breast cancer surgeries,
             mastectomies, breast reconstructions or implants

          -  Subjects with prior ipsilateral reduction mammoplasties (breast reductions) performed
             less than 2 years prior to enrollment to this study.

          -  Subjects previously treated with systemic therapies to treat the cancer to be removed
             during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal
             therapy.

          -  Subjects undergoing breast conserving surgery whose resected specimen (main lump,
             shaves, or any other resected tissue) will be evaluated with frozen section after the
             LUM-guided removal of shaves.