Investigation of Novel Surgical Imaging for Tumor Excision

NCT ID: NCT03686215

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2022-05-04

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 (LUM 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 Imaging 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, then the surgeon will complete the surgery per their standard practice. If the patient is randomized to the device arm, the surgeon will use the LUM Imaging 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Study Device Arm

Intervention Type: COMBINATION_PRODUCT

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

LUM Imaging System

Eligibility 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 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.

Exclusion Criteria

• Subjects must have organ and marrow function within limits as defined below:

• Leukocytes > 3,000/microlitre (mcL).
• Platelets > 75,000/mcL
• total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST (SGOT))/alanine transaminase (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 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Subjects who have been diagnosed with bilateral breast cancer and are undergoing bilateral resection procedure
• Subjects who are pregnant. Breastfeeding should be discontinued if the mothers is treated with Pegulicianine (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 hypertension (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, chronic obstructive pulmonary disease (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 specimen (main lump, shaves, or any other resected tissue) will be evaluated with frozen section after the LUM-guided removal of shaves.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Lumicell, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Smith, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Jorge Ferrer, PhD

Role: STUDY_DIRECTOR

Lumicell, Inc.

Locations

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

HonorHealth Research Institute

Scottsdale, Arizona, United States

Stanford Hospital and Clinics

Palo Alto, California, United States

Morton Plant Mease Health Care Oncology Research

Clearwater, Florida, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Comprehensive Breast Care Center/Beaumont Health

Royal Oak, Michigan, United States

Duke Cancer Center

Durham, North Carolina, United States

Novant Health Salem Surgical Associates

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

CHI Franciscan Research Center

Tacoma, Washington, United States

Countries

United States

References

Smith BL, Hunt KK, Carr D, Blumencranz PW, Hwang ES, Gadd MA, Stone K, Dyess DL, Dodge D, Valente S, Dekhne N, Clark P, Lee MC, Samiian L, Lesnikoski BA, Clark L, Smith KP, Chang M, Harris DK, Schlossberg B, Ferrer J, Wapnir IL. Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery. NEJM Evid. 2023 Jul;2(7):EVIDoa2200333. doi: 10.1056/EVIDoa2200333. Epub 2023 Apr 27.

Reference Type: DERIVED

PMID: 38320161 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

5R44CA211013-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CL0007

Identifier Type: -

Identifier Source: org_study_id