Investigation of Novel Surgical Imaging for Tumor Excision (INSITE)
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|ClinicalTrials.gov Identifier: NCT03686215|
Recruitment Status : Active, not recruiting
First Posted : September 26, 2018
Last Update Posted : October 19, 2021
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 (Lumicell 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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Combination Product: Study Device Arm||Phase 3|
All subjects will be injected with LUM015. The injection of the study drug will occur 2-6 hours prior to surgery at a dose of 1.0 mg/kg. Surgeons will complete the standard of care lumpectomy. Prior to removing any shaves as part of the standard of care, the surgeon will use the Lum System to scan and image the cavity where shaves will be obtained. The system will not provide guidance. The intent of the standard of care lumpectomy procedure is to achieve negative margins.
Randomization of whether the patient will receive the device will be revealed after the completion of the standard of care lumpectomy. If the patient is randomized to the non-device arm, than the surgeon will complete the surgery per their standard practice. If the patient is randomized to the device arm, the surgeon will use the Lumicell device to scan inside the lumpectomy cavity to indicate areas that may contain residual tumor. If the imaging system 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 in each orientation.
Study treatment ends when the surgery is completed. All patients will continue their enrollment in the study until their first follow-up visit and they will continue to be followed until the medical team determines no further surgical intervention is required. Patients who have consented to completing Quality of Life Questionnaires will be in the study until the schedule of questionnaires is complete. Patients with adverse events that are determined to be possibly related to the LUM Imaging System will be followed until resolution or stabilization of the adverse event.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||406 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will be randomized to receive the device intervention. All subjects will receive the study drug.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Masking will only be applied until the standard of care surgery is complete. At time of randomization, the study arm will be revealed to the study team. The pathologist will be masked to the type of tissue obtained from the patient.|
|Official Title:||Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer|
|Actual Study Start Date :||November 4, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||June 2022|
Experimental: Device Intervention: LUM Imaging System used during surgery
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.
Combination Product: Study Device Arm
LUM015 will be administered 2 to 6 hours prior to surgery. The LUM Imaging device will be used to assist in the removal of additional tumor tissue.
Other Name: LUM Imaging System
No Intervention: Standard of Care Arm
The LUM Imaging Device will not be used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.
- Ratio of patients who have residual cancer found in at least one Lumicell guided shave among all patients. [ Time Frame: 10-14 days ]Residual cancer is defined as tumor found by pathology in a therapeutic shave after the SOC surgical procedure is completed; that is, tumor that current SOC surgery failed to remove.
- Sensitivity and specificity on a per-tissue basis [ Time Frame: 1 day ]Instrument diagnostic accuracy
- Proportion of patients with positive margins after standard of care breast-conserving surgery who have a LUM Imaging System signal in the cavity above the threshold as defined by the tumor detection algorithm [ Time Frame: 10-14 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686215
|United States, Alabama|
|University of South Alabama|
|Mobile, Alabama, United States, 36604|
|United States, Arizona|
|HonorHealth Research Institute|
|Scottsdale, Arizona, United States, 85258|
|United States, California|
|Stanford University Medical Center|
|Palo Alto, California, United States, 94304|
|United States, Florida|
|Comprehensive Breast Care Center|
|Clearwater, Florida, United States, 33756|
|Baptist MD Anderson Cancer Physicians|
|Jacksonville, Florida, United States, 32207|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Beaumont Royal Oak|
|Royal Oak, Michigan, United States, 48073|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Winston-Salem, North Carolina, United States, 27103|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Franciscan Breast Surgery|
|Tacoma, Washington, United States, 98405|
|Principal Investigator:||Barbara Smith, MD, PhD||Massachusetts General Hospital|
|Study Director:||Jorge Ferrer, PhD||Lumicell, Inc.|