Post-market safety check for LUMISIGHT during lumpectomy
Official title: Post-market Evaluation of Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration
Run by Lumicell, Inc. · NCT07572162 · Data updated 2026-11-12
This study tests how often serious allergic reactions happen in adults with breast cancer who receive LUMISIGHT during lumpectomy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Lumicell, Inc. Industry-sponsored |
| Locations | 2 sites (Mobile, Alabama and 1 other locations) |
| Status | Recruiting |
| Started | September 30, 2026 |
| Main results expected | December 2030 |
| Study ends | December 2030 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07572162 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with primary breast cancer scheduled for lumpectomy who are indicated to receive LUMISIGHT at 1 mg/kg.
✕Probably not a fit
Patients without hypersensitivity risk or who do not experience adverse reactions may derive no direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multi-center observational study that follows adults with primary breast cancer undergoing lumpectomy and receiving LUMISIGHT as part of their care. The study tracks adverse events related to LUMISIGHT, including anaphylaxis and other severe hypersensitivity reactions, with safety data collected before and after administration. Adverse events, vital signs, and laboratory data are reviewed, and suspected cases are adjudicated by a clinical endpoint committee. There is no experimental drug involved; it assesses real-world post-market safety of the approved agent.
Why it matters
Potential benefit: If successful, the study could better define the safety profile of LUMISIGHT and help clinicians manage hypersensitivity risks.
How similar studies have gone: Previous post-market safety efforts for similar imaging agents have informed risk management; this study extends that approach to LUMISIGHT.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Has been diagnosed with primary breast cancer and scheduled to undergo a lumpectomy procedure * Indicated to receive LUMISIGHT at a dose of 1 mg/kg * Willing and able to comply with the study procedures Exclusion Criteria: * History of hypersensitivity reactions to pegulicianine. * Inability to comply with the requirements of the protocol. * Treating physician does not think it is in the best interest of the patient to participate.
Where it's running
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University of South Alabama Health
Mobile, Alabama, United States Recruiting -
Stanford University
Palo Alto, California, United States Recruiting
Study contacts
- Principal investigator: Jorge Ferrer, PhD — Lumicell, Inc.
- Study coordinator: VP, Clinical Affairs and Pharmacovigilance
- Email: kate@lumicell.com
- Phone: 6174041033
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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LumiSystem in breast-conserving surgery: real-world use after market release
This registry tests how LumiSystem is used in real patient care during lumpectomies and what outcomes it may be related to in adults with breast cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.