Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility
Overview
This is a minimal risk post-market registry study conducted at participating clinical institutions that are utilizing LumiSystem consistent with the U.S. Food and Drug Administration (FDA) approved indication for use to collect data on the use of LumiSystem in a real-world setting to support the evaluation of safety, effectiveness, clinical utility (including impact to healthcare utilization and surgical management), and product and quality improvements.
Detailed description
Lumicell Inc. has developed LumiSystem, a combination product consisting of LUMISIGHT (pegulicianine), an optical imaging agent, and Lumicell Direct Visualization System (DVS), a fluorescence imaging device. U.S. Food and Drug Administration (FDA) approved this combination product on April 17, 2024, for the following indication for use: LUMISIGHT and Lumicell DVS are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. This registry study aims to enroll patients for whom LumiSystem has been clinically indicated and used commercially. This protocol does not direct patient care. This protocol directs the documentation of information about the care and procedures being provided to patients when using LumiSystem consistent with its approved labeling. This registry study will collect data on the use of LumiSystem in a real-world setting.
Primary outcome measures
- Characterize removal of residual cancer in the lumpectomy bed of breast cancer patients. [Time frame: Approximately 7 days]
Secondary outcome measures (6)
- Determine change in margin status after using LumiSystem [Time frame: Up to approximately 6 weeks]
- Determine impact to adjuvant radiotherapy treatment after using LumiSystem. [Time frame: Up to approximately 9 months]
- Determine impact to surgical intervention after using LumiSystem [Time frame: Up to approximately 6 weeks]
- Compare LumiSystem performance against standard of care (SoC) [Time frame: Up to approximately 6 weeks]
- Report on healthcare utilization for patients undergoing breast conserving surgery (BCS) with LumiSystem. [Time frame: Up to approximately 8 weeks]
- Identification of safety signals. [Time frame: 7 days]
Eligibility criteria
Inclusion criteria
- Participant must be consistent with FDA approved indication
Exclusion criteria
- Participant is enrolled in a clinical trial using an investigational product directing tissue removal during the lumpectomy procedure
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Smith BL, Hunt KK, Carr D, Blumencranz PW, Hwang ES, Gadd MA, Stone K, Dyess DL, Dodge D, Valente S, Dekhne N, Clark P, Lee MC, Samiian L, Lesnikoski BA, Clark L, Smith KP, Chang M, Harris DK, Schlossberg B, Ferrer J, Wapnir IL. Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery. NEJM Evid. 2023 Jul;2(7):EVIDoa2200333. doi: 10.1056/EVIDoa2200333. Epub 2023 Apr 27. PMID 38320161
Identifiers
NCT: NCT07616856 · CLP00205