Intraoperative Detection of Residual Cancer in Breast Cancer

NCT03321929 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 2 other identifiers: CL00065R44CA211013-02
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Collect Data to Refine and Verify the Tumor Detection Algorithm.

  Data were collected from mITT population, which included all the patients imaged with the LUM Imaging System. This metric measured the residual cancer that current Standard of Care (SOC) lumpectomy failed to remove. It was defined as among all the patients, the percentage of subjects who had residual cancer found in at least one LUM-guided shave (therapeutic shave or "T-shave") after the current initial SOC lumpectomy procedure was completed.

  1 day

Secondary Outcomes (8)

• Number of Patients With Reported Adverse Events

  Patients were evaluated for adverse events from time of injection until standard post-surgery follow-up visit (Median 31 days after lumpectomy).

• Tumor Removal Rate in the Whole mITT Population by SOC Margin Status

  1 week

• Tumor Removal Rate Within Subjects Having Positive Standard of Care Margins

  1 Week

• Tumor Removal Rate Within Subjects Having All Negative SOC Margins

  1 Week

• Sensitivity and Specificity of the LUM Imaging System in Predicting Residual Cancer in the Cavity

  1 Week

Other Outcomes (1)

• Number of Surgeons Trained on the Use of the LUM Imaging System

  1 day

Study Arms (1)

LUM Imaging System

EXPERIMENTAL

Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device

Combination Product: LUM Imaging System

Interventions

LUM Imaging System COMBINATION_PRODUCT

Drug: LUM015 Device: LUM 2.6 Imaging Device

Also known as: LUM015

LUM Imaging System

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects who are treated for bilateral breast cancer resection procedure.
• 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.

Sponsors & Collaborators

• Lumicell, Inc.: lead
• National Cancer Institute (NCI): collaborator

Study Sites (16)

University of South Alabama

Mobile, Alabama, 36604, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

Comprehensive Breast Care Center

Clearwater, Florida, 33756, United States

Location

Baptist MD Anderson Cancer Physicians

Jacksonville, Florida, 32207, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Beaumont Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Beaumont Troy

Troy, Michigan, 48098, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Novant Health

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Dallas Breast Center

Dallas, Texas, 75231, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Franciscan Breast Surgery

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• Hwang ES, Beitsch P, Blumencranz P, Carr D, Chagpar A, Clark L, Dekhne N, Dodge D, Dyess DL, Gold L, Grobmyer S, Hunt K, Karp S, Lesnikoski BA, Wapnir I, Smith BL; INSITE study team. Clinical Impact of Intraoperative Margin Assessment in Breast-Conserving Surgery With a Novel Pegulicianine Fluorescence-Guided System: A Nonrandomized Controlled Trial. JAMA Surg. 2022 Jul 1;157(7):573-580. doi: 10.1001/jamasurg.2022.1075.

  PMID: 35544130 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Protocol deviations may have impacted the reported performance. In some patients no LUM shaves were removed either because of protocol deviation or because the protocol limited the number of additional shaves that could be excised at any single margin. These deviations may have precluded full pathologic correlation and evaluation of clinical utility for many of the LUM images and may have prevented conversion of positive margins to negative margins.

Results Point of Contact

• Title: Jorge Ferrer, PhD
• Organization: Lumicell

jmferrer@lumicell.com

617-571-0592

Study Officials

• Barbara Smith, M.D., Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 26, 2017
• Study Start: February 6, 2018
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: May 1, 2023
• Results First Posted: May 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)