Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry (IMPACT)

Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: VP, Clinical Affairs and Pharmacovigilance; Phone Number: 16174041033; Email: kate@lumicell.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a post-market registry study enrolling participants for whom LumiSystem was used during lumpectomy consistent with the FDA-approved indication for use

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Post market LumiSystem population consistent with FDA approved labeling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Lumicell, Inc.

Publications and helpful links

General 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.

Helpful Links

• Lumicell sponsored product website

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Fluorescence guided surgery; Lumicell; LumiSystem; intraoperative margin detection; Lumisight; pegulicianine
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: CLP00205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: IPD from an institution will be shared with investigators from that institution who request this data for further analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL