Intraoperative Detection of Residual Cancer in Breast Cancer

Not Recruiting

Trial ID: NCT03321929


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.

Official Title

Feasibility Study Phase C: Expansion Into Multiple Institutions for Training in the Use of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects With Breast Cancer

Stanford Investigator(s)

Irene Wapnir, MD
Irene Wapnir, MD

Professor of Surgery (General Surgery)


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

   - 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

   - Subjects undergoing breast conserving surgery whose resected specimen will be
   evaluated with frozen section.


combination product: LUM Imaging System

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kathryn Bucknell

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