Intraoperative Detection System for Breast Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byBarbara Smith, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Lumicell, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Barbara Smith, MD, PhD

Principal Investigator

Massachusetts General Hospital

Jorge Ferrer, PhD

Principal Investigator

Lumicell, Inc.

Eligibility Criteria

This trial is for women over 18 with confirmed invasive breast cancer or DCIS who are scheduled for a lumpectomy after neoadjuvant therapy. They must be able to follow the study, have signed consent, and not have serious medical issues. Exclusions include pregnancy, uncontrolled health problems like high blood pressure or infections, allergies to certain agents including PEG, recent investigational drugs use, HIV-positive on antiretrovirals, prior ipsilateral breast surgeries less than 2 years ago.

Inclusion Criteria

I am willing and able to follow the study's procedures and instructions.

You have a low level of white blood cells.

Your platelet count is higher than 50,000 per microliter.

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Exclusion Criteria

Any subject for whom the investigator feels participation is not in the best interest of the subject.

I had a breast reduction on the same side less than 2 years ago.

You have had an allergic reaction to polyethylene glycol (PEG) in the past.

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Treatment Details

Interventions

LUM Imaging System (Imaging Agent)

Trial OverviewThe LUM Imaging System is being tested in this study. It's used during breast conserving surgery to detect any residual cancer that might remain post-operation. The trial involves patients at multiple centers who are randomly assigned to receive this new imaging technology as part of their surgical treatment.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Standard of Care ArmExperimental Treatment1 Intervention

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

Group II: Device Intervention: LUM Imaging System used during surgeryExperimental Treatment2 Interventions

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