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Feasibility Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients Receiving Neoadjuvant Therapy

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: NCT04440982
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : November 9, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Massachusetts General Hospital
Information provided by (Responsible Party):
Lumicell, Inc.

Brief Summary:
This is a prospective, multi-center, two-arm, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.

Condition or disease Intervention/treatment Phase
Breast Cancer Neoadjuvant Therapy Combination Product: Study Device Arm Phase 2

Detailed Description:

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 perform main specimen resection per standard of care. Prior to removing any shaves as part of the standard of care, the surgeon will use the Lum System to scan and image all orientations within the cavity. The LUM Imaging System will guide shave removal. Then, comprehensive shaved margins are removed.

In this study, the initial cohort is a "training set" with 10 patients receiving neoadjuvant therapy to refine the tumor detection algorithm, if needed. After completion of enrollment of the initial 10 subjects for algorithm training, the Investigators will then enroll a cohort of patients who received neoadjuvant therapy to further evaluate the performance of the LUM Imaging System in this important subset of breast cancer patients. Patients will be randomized 3:1 to a LUM-assisted lumpectomy versus a standard lumpectomy. In both arms, shaved margins will be taken from the entire lumpectomy cavity to compare the extent of residual tumor after standard and LUM-assisted lumpectomies to evaluate the negative predictive value of the LUM Imaging System following neoadjuvant therapy. The LUM Imaging System will be used in both arms to capture images of each tissue removed, whether LUM-guided or part of the final comprehensive shave removal. Data from both arms of the study will be used to determine the diagnostic performance (sensitivity and specificity) of the LUM Imaging System in patients who have received neoadjuvant therapy. Only the group of patients randomized to the device (intervention) arm will have the LUM Imaging System guide the removal of tissue prior to the removal of final comprehensive shaves of the entire cavity.

Study treatment ends when the surgery is completed. Patients are followed for adverse events until their standard of care follow-up visit or after any secondary surgery, whichever is longer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
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: Single (Investigator)
Masking Description: Masking will only be applied until main lumpectomy is removed. At time of randomization, the study arm will be revealed to the study team.
Primary Purpose: Other
Official Title: Feasibility Study to Evaluate Performance of the LUM Imaging System for Intraoperative Detection of Residual Tumor in Patients With Breast Cancer Receiving Neoadjuvant Therapy
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

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.



Primary Outcome Measures :
  1. Sensitivity and specificity of the system will be evaluated by comparing the imaging result with pathology findings of the imaged tissue [ Time Frame: 1 month ]
    Refining of the previously validated tumor detection algorithm in breast cancer patients receiving neoadjuvant therapy will be conducted in the first cohort and the validation of this algorithm will use data from the second cohort.

  2. Number of patients with reported adverse events [ Time Frame: 14 days ]
    Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 have received neoadjuvant therapy for this breast cancer diagnosis prior to their lumpectomy procedure.
  • 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.

    • Leukocytes > 1,000/mcL
    • Platelets > 50,000/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 at the time of diagnosis of their breast cancer. 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.
  • Subjects who have taken an investigational drug within 14 days of enrollment.
  • Subjects who will have administration of methylene blue or any blue or green 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 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 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 undergoing breast conserving surgery whose resected specimen (main lump, shaves, or any other resected tissue) will be evaluated with frozen section after the Lumicell-guided removal of shaves.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440982


Contacts
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Contact: Jorge Ferrer, PhD 617-404-1040 jmferrer@lumicell.com
Contact: Kate Smith, MPH, CCRP 617-404-1033 kate@lumicell.com

Locations
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United States, California
Stanford University Medical Center Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Irene Wapnir, MD         
Principal Investigator: Irene Wapnir, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Barbara Smith, MD, PhD         
Principal Investigator: Barbara Smith, MD, PhD         
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Shelley Hwang, MD         
Principal Investigator: Shelley Hwang, MD         
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Kelly Hunt, MD         
Principal Investigator: Kelly Hunt, MD         
Sponsors and Collaborators
Lumicell, Inc.
National Cancer Institute (NCI)
Massachusetts General Hospital
Investigators
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Principal Investigator: Barbara Smith, MD, PhD Massachusetts General Hospital
Study Director: Jorge Ferrer, PhD Lumicell, Inc.
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Responsible Party: Lumicell, Inc.
ClinicalTrials.gov Identifier: NCT04440982    
Other Study ID Numbers: CLP0008
1R01CA212138-01 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Lumicell, Inc.:
breast cancer surgery
lumpectomy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases