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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03686215
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : November 9, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lumicell, Inc.

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE September 26, 2018
Last Update Posted Date November 9, 2020
Actual Study Start Date  ICMJE November 4, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
  • Ratio of patients who have residual cancer found in at least one Lumicell guided shave among all patients. [ Time Frame: 10-14 days ]
    Residual cancer is defined as tumor found by pathology in a therapeutic shave after the SOC surgical procedure is completed; that is, tumor that current SOC surgery failed to remove.
  • Sensitivity and specificity on a per-tissue basis [ Time Frame: 1 day ]
    Instrument diagnostic accuracy
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
Proportion of LUM Imaging System detection of cancer in the cavity in subjects with pathology-positive margins after standard of care breast-conserving surgery [ Time Frame: 10-14 days ]
Positive Margin Population: Lumicell imaged subjects with positive margins by pathology of the outermost SOC specimen prior to any use of Lumicell imaging without any major protocol violations.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
Proportion of patients with positive margins after standard of care breast-conserving surgery who have a LUM Imaging System signal in the cavity above the threshold as defined by the tumor detection algorithm [ Time Frame: 10-14 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
Proportion of subjects with pathology-positive margins after standard of care breast-conserving surgery for whom additional LUM Imaging System-guided shaves resulted in pathology-negative margins [ Time Frame: 10-14 days ]
This endpoint also estimates the potential reduction in re-excision surgeries following standard of care breast-conserving surgery that resulted from a positive SOC margin.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pivotal Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients
Official Title  ICMJE Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer
Brief 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 (Lumicell 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.

Detailed Description

All subjects will be injected with LUM015. The injection of the study drug will occur 2-6 hours prior to surgery at a dose of 1.0 mg/kg. Surgeons will complete the standard of care lumpectomy. Prior to removing any shaves as part of the standard of care, the surgeon will use the Lum System to scan and image the cavity where shaves will be obtained. The system will not provide guidance. The intent of the standard of care lumpectomy procedure is to achieve negative margins.

Randomization of whether the patient will receive the device will be revealed after the completion of the standard of care lumpectomy. If the patient is randomized to the non-device arm, than the surgeon will complete the surgery per their standard practice. If the patient is randomized to the device arm, the surgeon will use the Lumicell device to scan inside the lumpectomy cavity to indicate areas that may contain residual tumor. If the imaging system 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 who have consented to completing Quality of Life Questionnaires will be in the study until the schedule of questionnaires is complete. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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.
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Combination Product: Study Device Arm
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.
Other Name: LUM Imaging System
Study Arms  ICMJE
  • Experimental: Device Intervention: LUM Imaging System used during surgery
    The LUM Imaging Device will be used 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. Patients in this arm will receive the study drug, LUM015.
    Intervention: Combination Product: Study Device Arm
  • No Intervention: Standard of Care Arm
    The LUM Imaging Device will not be used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2019)
170
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2018)
250
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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/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 have been diagnosed with bilateral breast cancer and are undergoing bilateral 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 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 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 speciment (main lump, shaves, or any other resected tissue) will be evaluated with frozen section after the Lumicell-guided removal of shaves.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jorge Ferrer, Ph.D. 617-404-1040 jmferrer@lumicell.com
Contact: Kate Smith, MPH, CCRP 617-404-1033 kate@lumicell.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03686215
Other Study ID Numbers  ICMJE CL0007
5R44CA211013-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lumicell, Inc.
Study Sponsor  ICMJE Lumicell, Inc.
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Barbara Smith, MD, PhD Massachusetts General Hospital
Study Director: Jorge Ferrer, PhD Lumicell, Inc.
PRS Account Lumicell, Inc.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP