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Imaging Agent

Intraoperative Detection System for Breast Cancer

Phase 2

Waitlist Available

Led By Barbara Smith, MD, PhD

Research Sponsored by Lumicell, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Subjects must have received neoadjuvant therapy for this breast cancer diagnosis prior to their lumpectomy procedure (cohorts 1 and 2).

Must not have

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 have been diagnosed with bilateral breast cancer and are undergoing bilateral resection procedure.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new system to see if it helps doctors better treat breast cancer patients during surgery.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Specific side effects related to the LUM Imaging System aren't detailed here but may include reactions similar to those from other contrast agents such as allergic reactions or discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a type of breast cancer or DCIS.

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I received treatment before my breast lump removal surgery.

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I am scheduled for a lumpectomy due to breast cancer.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding if I am to be treated with LUM015.

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I have cancer in both breasts and will have surgery to remove both.

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I do not have any severe illnesses or mental health issues that would stop me from following the study's requirements.

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I am not on HIV medication due to potential drug interactions.

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I have had surgery, mastectomy, reconstruction, or implants in the breast with cancer before.

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I will receive a dye for lymph node mapping before lumpectomy imaging.

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I am having a second lumpectomy due to cancer cells found at the edge of my first surgery's tissue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Number of patients with reported adverse events

Reduction in residual tumor

+1 more

Side effects data

From 2022 Phase 3 trial • 406 Patients • NCT03686215

91%

Chromaturia

Seroma

Breast pain

Nausea

Procedural pain

Erythema

Fatigue

Pruritus

Constipation

Blood creatinine decreased

Rash

Ecchymosis

Contusion

Haematoma

100%

80%

60%

40%

20%

Study treatment Arm

Device Intervention: LUM Imaging System Used During Surgery

Standard of Care Arm

Withdrawn Before Randomization

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Device Intervention: LUM Imaging System used during surgeryExperimental Treatment1 Intervention

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 II: Standard of Care ArmActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Study Device Arm

2019

Completed Phase 3

~410

0 / 11Eligibility criteria met