Breast Cancer
Conditions
Keywords
Breast Cancer, Fluorescence guided surgery, intraoperative margin detection, LumiSystem, Lumicell, Lumisight, pegulicianine
Brief summary
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.
Interventions
None listed
Sponsors
Lumicell, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize removal of residual cancer in the lumpectomy bed of breast cancer patients. | Approximately 7 days | Proportion of patients who have residual cancer found in at least one LumiSystem-guided shave among all patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine change in margin status after using LumiSystem | Up to approximately 6 weeks | Proportion of patients with at least one positive margin on the index standard lumpectomy that were converted to final negative margins after usual care due to LumiSystem directed shaves among all patients and Proportion of patients with at least one positive margin on index standard lumpectomy that were converted to final negative margins after usual care due to LumiSystem directed shaves among patients with at least one positive margin on standard lumpectomy. |
| Determine impact to adjuvant radiotherapy treatment after using LumiSystem. | Up to approximately 9 months | Proportion of patients whose adjuvant radiotherapy treatment provider reported a change in treatment recommendation or plan due to information received by use of LumiSystem. |
| Determine impact to surgical intervention after using LumiSystem | Up to approximately 6 weeks | Assess clinical utility of LumiSystem use. |
| Compare LumiSystem performance against standard of care (SoC) | Up to approximately 6 weeks | Proportion of LumiSystem-guided shaves that did not contain residual cancer taken after negative margins vs. proportion of standard of care (SoC) shaves that did not contain residual cancer taken after negative margins and proportion of LumiSystem-guided shaves taken after positive margins among positive margins vs. proportion of SoC shaves after positive margins among positive margins. |
| Report on healthcare utilization for patients undergoing breast conserving surgery (BCS) with LumiSystem. | Up to approximately 8 weeks | Change in healthcare utilization associated with use of LumiSystem |
| Identification of safety signals. | 7 days | Rate of adverse events and adverse device effects. |
Contacts
CONTACTVP, Clinical Affairs and Pharmacovigilance
Outcome results
None listed