Intraoperative Detection of Residual Cancer in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Neoplasm, Residual
Intervention: LUM Imaging System
Intervention description: Drug: LUM015 Device: LUM 2.6 Imaging Device
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 234.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a non-randomized, open-label, multi-site study to collect safety and efficacy data on
      an intraoperative imaging system, the LUM Imaging System (LUM015 imaging agent in conjunction
      with the LUM imaging device), in identifying residual cancer in the tumor bed of female
      breast cancer patients. During the study, study physicians and clinical staff will complete
      hands-on training in anticipation of the upcoming pivotal study. Site-specific or
      user-specific issues related to the use of the device will be identified and addressed.
      Additionally, the data collected in the study will be used to continue training the tumor
      detection algorithm of the device.

      In this study, patients will be injected with LUM015 prior to surgery. The study physicians
      will perform lumpectomy procedures according to his or her institution's standard of care
      practice. After the main specimen removal is completed, the study physician will use the LUM
      Imaging Device to image the tumor bed. Therapeutic shaves will be removed based on the
      recommendation 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 a combination of invasive breast cancer and
             DCIS. The protocol accepted methods for obtaining the histological samples are
             diagnostic core needle biopsies or fine needle biopsies.

          -  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.

          -  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 cancer, as per the exclusion criteria listed below.

          -  Subjects must have normal organ and marrow function within limits as defined below:

               -  Leukocytes > 3,000/mcL

               -  Platelets > 75,000/mcL

               -  total bilirubin within normal institutional limits

               -  AST (SGOT)/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.

        Exclusion criteria:

          -  Subjects who are treated for bilateral breast cancer resection procedure.

          -  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.

          -  Subjects who are sexually active and not willing/able to use 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. 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.

          -  Subjects who have taken an investigational drug within 30 days of enrollment.

          -  Subjects with prolonged QTc interval defined as greater than 480 ms.

          -  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 HTN
             should be stable within these ranges while under pharmaceutical therapy.

          -  History of allergic reaction attributed to drugs containing 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 because
             of the potential for pharmacokinetic interactions with LUM015.

          -  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 prior ipsilateral breast cancer surgeries, mastectomies, breast
             reconstructions or implants.

          -  Subjects who have undergone a surgical biopsy for any reason in the ipsilateral breast
             performed less than 2 years prior to enrollment of this study.

          -  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 will be
             evaluated with frozen section.