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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post market LumiSystem population consistent with FDA approved labeling | Post market LumiSystem population consistent with FDA approved labeling |
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| Measure | Description | Time Frame |
|---|---|---|
| Characterize removal of residual cancer in the lumpectomy bed of breast cancer patients. | Proportion of patients who have residual cancer found in at least one LumiSystem-guided shave among all patients. | Approximately 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Determine change in margin status after using LumiSystem | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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This is a post-market registry study enrolling participants for whom LumiSystem was used during lumpectomy consistent with the FDA-approved indication for use
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Affairs and Pharmacovigilance | Contact | 16174041033 | kate@lumicell.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38320161 | Background | 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. |
| Label | URL |
|---|---|
| Lumicell sponsored product website | View source |
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Two types of summary reports will be generated annually and shared with the site Investigators: i) one report will summarize the overall dataset ii) the second report will include the site's summary data from their own institute including benchmarks relative to the average without disclosure of the results of other institutions. IPD from an institution will be shared with investigators from that institution who request this data for further analysis.
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IPD from an institution will be shared with investigators from that institution who request this data for further analysis.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Up to approximately 6 weeks |
| Determine impact to adjuvant radiotherapy treatment after using LumiSystem. | Proportion of patients whose adjuvant radiotherapy treatment provider reported a change in treatment recommendation or plan due to information received by use of LumiSystem. | Up to approximately 9 months |
| Determine impact to surgical intervention after using LumiSystem | Assess clinical utility of LumiSystem use. | Up to approximately 6 weeks |
| Compare LumiSystem performance against standard of care (SoC) | 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. | Up to approximately 6 weeks |
| Report on healthcare utilization for patients undergoing breast conserving surgery (BCS) with LumiSystem. | Change in healthcare utilization associated with use of LumiSystem | Up to approximately 8 weeks |
| Identification of safety signals. | Rate of adverse events and adverse device effects. | 7 days |
| D017437 |
| Skin and Connective Tissue Diseases |