Investigation of Novel Surgical Imaging for Tumor Excision
(INSITE Trial)

Recruiting in Palo Alto (17 mi)

+23 other locations

Overseen byBarbara Smith, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Lumicell, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients undergoing breast surgery in order to assist surgeons in reducing the rates of positive margins. All enrolled subjects will be injected with LUM015 prior to surgery. Surgeons are blinded to whether a participant will be randomized into the device arm until after the standard of care lumpectomy is complete. Participants will then be randomized to receiving the device. Therapeutic (LUM guided) shaves will be removed based on the guidance of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.

Research Team

Jorge Ferrer, PhD

Principal Investigator

Lumicell, Inc.

Barbara Smith, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

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 be scheduled for a lumpectomy for a breast malignancy.

See 3 more

Treatment Details

Interventions

LUM Imaging System (Procedure)

Participant Groups

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.