Pivotal Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients



Status:Not yet recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:2/10/2019
Start Date:March 2019
End Date:December 2019
Contact:Felix Geissler, MD, PhD
Email:felix@lumicell.com
Phone:781-591-8378

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Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer

This is a multi-center, single-arm 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 in order to assist surgeons in reducing the rates of
positive margins.

In this study, patients will be injected with LUM015 prior to surgery. The study physician
should perform their standard of care lumpectomy, which may include the removal of shaves.
Therapeutic (Lumicell guided) shaves will be removed based on the recommendation of the LUM
Imaging System after the standard of care lumpectomy. Patients will be followed until their
first standard of care post-operative follow-up visit.

For breast cancer lumpectomies, the presence of residual cancer cells left in the tumor bed
after initial resection is inferred by post-operative margin assessment of the resected
tissue by a pathologist.

The injection of the study drug will occur 2-6 hours prior to surgery at a dose of 1.0 mg/kg.
The surgeon will complete the lumpectomy and remove any standard of care shaves if
applicable. The surgeon will use the Lumicell device to look inside the lumpectomy cavity to
see if the dye indicates any areas that may contain residual tumor. If the imaging identifies
that there may be cancer cells remaining in the lumpectomy cavity, the surgeon will remove an
additional piece of tissue. This process will be continued until a negative reading from the
device is obtained or a maximum of 2 shaves of additional tissue has been removed in each
orientation.

Study treatment ends when the surgery is completed. All patients will continue their
enrollment in the study until their first follow-up visit and they will continue to be
followed until the medical team determines no further surgical intervention is required.
Patients with adverse events that are determined to be possibly related to the LUM Imaging
System will be followed until resolution or stabilization of the adverse event.

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 21 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/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.

- Subjects with ECOG performance status of 0 or 1.

Exclusion Criteria:

- Subjects who are treated for bilateral breast cancer resection procedure

- Subjects who are pregnant. Breastfeeding should be discontinues if the mothers is
treated with 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 HTN
should be stable with controlled HTN while under pharmaceutical therapy.

- History of allergic reaction attributed to any contrast agent or 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.

- 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 speciment will be
evaluated with frozen section.
We found this trial at
16
sites
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Barbara Smith, MD, PhD
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Burlington, Massachusetts 01805
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Clearwater, Florida 33756
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Dallas, Texas 75231
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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Jacksonville, Florida 32207
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307 N University Blvd
Mobile, Alabama 36688
(251) 460-6101
University of South Alabama "University of South Alabama is a public institution that was founded...
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Palo Alto, California 94304
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Royal Oak, Michigan 48073
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Tacoma, Washington 98405
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Troy, Michigan 48098
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2025 Frontis Plaza Boulevard
Winston-Salem, North Carolina 27103
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