Investigation of Novel Surgical Imaging for Tumor Excision (INSITE)
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ClinicalTrials.gov Identifier: NCT03686215 |
Recruitment Status :
Completed
First Posted : September 26, 2018
Results First Posted : August 24, 2023
Last Update Posted : August 24, 2023
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Tracking Information | |||||||
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First Submitted Date ICMJE | September 25, 2018 | ||||||
First Posted Date ICMJE | September 26, 2018 | ||||||
Results First Submitted Date ICMJE | May 5, 2023 | ||||||
Results First Posted Date ICMJE | August 24, 2023 | ||||||
Last Update Posted Date | August 24, 2023 | ||||||
Actual Study Start Date ICMJE | November 4, 2019 | ||||||
Actual Primary Completion Date | December 9, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Proportion of LUM Imaging System detection of cancer in the cavity in subjects with pathology-positive margins after standard of care breast-conserving surgery [ Time Frame: 10-14 days ] Positive Margin Population: Lumicell imaged subjects with positive margins by pathology of the outermost SOC specimen prior to any use of Lumicell imaging without any major protocol violations.
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Proportion of subjects with pathology-positive margins after standard of care breast-conserving surgery for whom additional LUM Imaging System-guided shaves resulted in pathology-negative margins [ Time Frame: 10-14 days ] This endpoint also estimates the potential reduction in re-excision surgeries following standard of care breast-conserving surgery that resulted from a positive SOC margin.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Investigation of Novel Surgical Imaging for Tumor Excision | ||||||
Official Title ICMJE | Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer | ||||||
Brief Summary | 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. |
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Detailed Description | 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 Imaging 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, then the surgeon will complete the surgery per their standard practice. If the patient is randomized to the device arm, the surgeon will use the LUM Imaging 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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized 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. Primary Purpose: Treatment
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Condition ICMJE | Breast Cancer | ||||||
Intervention ICMJE | 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
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
406 | ||||||
Original Estimated Enrollment ICMJE |
250 | ||||||
Actual Study Completion Date ICMJE | May 4, 2022 | ||||||
Actual Primary Completion Date | December 9, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
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Administrative Information | |||||||
NCT Number ICMJE | NCT03686215 | ||||||
Other Study ID Numbers ICMJE | CL0007 5R44CA211013-02 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Lumicell, Inc. | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Lumicell, Inc. | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||
Investigators ICMJE |
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PRS Account | Lumicell, Inc. | ||||||
Verification Date | July 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |