About This Study

Females age 18 or older, diagnosed with primary invasive breast cancer and or ductal carcinoma in situ (DCIS) and scheduled for lumpectomy are eligible to participate. The INSITE study evaluates a novel drug (pegulicianine) and Lumicell’s imaging system for safety and efficacy in identifying and guiding removal of cancer remaining in the surgical cavity after the standard lumpectomy, with the goal of reducing the risk of repeat surgeries.

Pegulicianine is designed to fluoresce – or light up – in the presence of cancer cells to help surgeons differentiate between healthy and abnormal tissue. After your surgeon completes the standard lumpectomy procedure, your surgeon will scan the surgical cavity with Lumicell’s imaging system to identify and remove residual disease. The Lumicell technology has been used in multiple clinical studies in over 500 breast cancer patients.

My Treatment

Here is how your surgery and treatment plan will change if I you choose to participate in this study.

Surgery Timeline

Commonly Asked Questions

What is the purpose of the clinical study?
Breast-conserving surgery is a critical first step of treatment for many women with breast cancer. The goal is to remove all the cancer cells, leaving behind only healthy tissue. Unfortunately, approximately 1 in 4 women who undergo breast-conserving surgery require a second surgery to remove cancer cells that were left behind after the initial procedure. This study evaluates a novel drug (pegulicianine) and imaging system intended to help surgeons identify and remove cancer remaining in the surgical cavity after standard surgery, with the ultimate goal of helping reduce the risk of repeat surgeries.
You will receive the same standard lumpectomy procedure as well as pre- and post-operative care whether or not you participate in the study. However, study participants will also be administered the pegulicianine drug 2 to 6 hours prior to surgery, and may have additional imaging and tissue removal. Please refer to the study timeline for more information on the standard procedure and additional elements associated with the INSITE study.
For this study, patients are randomly assigned to either an intervention arm (10 of every 11 patients) or a control arm (1 of every 11 patients). For patients in the intervention arm, the surgeon will use the Lumicell imaging system to scan the cavity after the standard procedure, and will remove additional highlighted tissue if found; for patients in the control arm, the surgery will end after the standard procedure is complete.
If the surgeon identifies highlighted cells — i.e., possible residual cancer — using the Lumicell imaging system, a small amount of additional tissue will be removed as part of the study.
You will be in the study from time of enrollment (day of surgery) to your first follow-up visit (approximately 2 weeks), or if you choose to participate in an optional post-surgical survey, 3 to 6 months after your surgery. You will remain in the study until your physician indicates that there is no further surgery required.
Patients who have been injected with pegulicianine may notice blue/green discoloration of urine for 1 to 2 days after injection. This is a known effect of the dye, and is known not to be harmful to you.
No, pegulicianine contains no radioactive material.

How can I learn more?

Contact your doctor or enter your zip code below to find a doctor near you that is involved in the study.

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1 PENNSYLVANIA 1
2 FLORIDA 3
3 MASSACHUSETTS 1
4 NORTH CAROLINA 2
5 ALABAMA 1
6 OHIO 1
7 MICHIGAN 1
8 ARIZONA 1
9 CALIFORNIA 1
10 WASHINGTON 1
11 TEXAS 1