An observational study in Breast Cancer, sponsored by Lumicell, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Lumicell, Inc. · Observational
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Lumicell, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
This is a post-market registry study enrolling participants for whom LumiSystem was used during lumpectomy consistent with the FDA-approved indication for use
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Post market LumiSystem population consistent with FDA approved labeling
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.
Time frame: Approximately 7 days
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.
Time frame: 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.
Time frame: Up to approximately 9 months
Determine impact to surgical intervention after using LumiSystem
Assess clinical utility of LumiSystem use.
Time frame: 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.
Time frame: 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
Time frame: Up to approximately 8 weeks
Identification of safety signals.
Rate of adverse events and adverse device effects.
Time frame: 7 days
Plan to share: Yes — 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.
Supporting information: Study protocol
Access criteria: IPD from an institution will be shared with investigators from that institution who request this data for further analysis.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Lumicell, Inc.