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

NCT04440982 | Terminated Phase 2 DMC FDA Drug FDA Device

• 2 other identifiers: CLP00081R01CA212138-01
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Breast Cancer; Neoadjuvant Therapy

Keywords

breast cancer surgery; lumpectomy

Outcome Measures

Primary Outcomes (4)

• Development and validation of tumor detection algorithms in breast cancer patients receiving neoadjuvant therapy

  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.

  1 month

• Number of patients with reported adverse events

  Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.

  14 days

• Reduction in residual tumor

  Evaluate reduction in residual tumor left after Lumicell assisted lumpectomy compared with SoC removal of main lumpectomy specimen in patients who have received and not received neo-adjuvant therapy

  3 months

• Report on patient reported outcomes and patient preference information

  Collect and summarize patient reported information on outcomes and preference

  12 months

Study Arms (2)

Device Intervention: LUM Imaging System used during surgery

EXPERIMENTAL

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

Drug: LUM015; Device: Lum Imaging System

Standard of Care Arm

OTHER

The LUM Imaging Device will not be used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.

Drug: LUM015

Interventions

LUM015 DRUG

LUM015 will be administered 2 to 6 hours prior to surgery for both arms. The LUM Imaging device will be used to assist in the removal of additional tumor tissue in the device intervention arm.

Device Intervention: LUM Imaging System used during surgery; Standard of Care Arm

Lum Imaging System DEVICE

UM015 will be administered 2 to 6 hours prior to surgery for both arms. The LUM Imaging device will be used to assist in the removal of additional tumor tissue in the device intervention arm.

Device Intervention: LUM Imaging System used during surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• 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 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 (cohorts 1 and 2).
• 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:

• 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
• eGFR \>= 60mL/min/1.73m2
• Subjects with 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 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.
• Subjects with a history of allergic reaction to polyethylene glycol (PEG).
• Subjects with a history of allergic reaction to any oral or intravenous contrast agents.

Sponsors & Collaborators

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

Study Sites (6)

Stanford Hospital and Clinics

Palo Alto, California, 94304, United States

Location

Morton Plant Mease Health Care Oncology Research

Clearwater, Florida, 33756, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

Novant Health Cancer Center

Winston-Salem, North Carolina, 27103, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Barbara Smith, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Jorge Ferrer, PhD

  Lumicell, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Masking will only be applied until main lumpectomy is removed. At time of randomization, the study arm will be revealed to the study team.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to receive the device intervention. All subjects will receive the study drug.

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 22, 2020
• Study Start: September 1, 2020
• Primary Completion: November 30, 2023
• Study Completion: February 29, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)