Post-market Safety Study of LUMISIGHT

Post-market Evaluation of Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration

This study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with breast cancer undergoing lumpectomy surgery. Participants are indicated to receive LUMISIGHT as part of their breast cancer care. There is no investigational drug associated with this study. LUMISIGHT has a risk of serious hypersensitivity reaction, and this study seeks to further evaluate that risk.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypersensitivity Reactions

Detailed Description

The LumiSystem is the combination of FDA approved LUMISIGHT (pegulicianine) for injection (NDA 214511) and Lumicell Direct Visualization System (DVS) (PMA P230014). These products 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 post market study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with breast cancer undergoing lumpectomy surgery. Additional study objectives are to evaluate the incidence of and characterize other severe hypersensitivity reactions. Study assessments include assessment of adverse events of interest (including laboratory data as indicated in this protocol), physical examination, and assessment of blood pressure, heart rate, and oxygen saturation before and after LUMISIGHT administration. Suspected cases of anaphylaxis and hypersensitivity reactions are adjudicated by a Clinical Endpoint Adjudication Committee according to a standard anaphylaxis definition and hypersensitivity grading system.

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

Contacts and Locations

• Study Contact: Name: VP, Clinical Affairs and Pharmacovigilance; Phone Number: 6174041033; Email: kate@lumicell.com
• Study Contact Backup: Name: Senior Clinical Trial Manager; Email: ppalacios@lumicell.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The analysis population consists of the post-market safety population who are injected with LUMISIGHT. The post-market safety population is defined by the indication for use and contraindications as described in the Prescribing Information for LUMISIGHT under NDA 214511.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Post-market safety population injected with LUMISIGHT; The analysis population consists of the post-market safety population who are injected with LUMISIGHT. The post-market safety population is defined by the indication for use and contraindications as described in the Prescribing Information for LUMISIGHT under NDA 214511.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adjudicated anaphylaxis	Evaluate the rate of adjudicated anaphylaxis observed within 60-minutes post-injection of LUMISIGHT	75 +/- 15 minutes post LUMISIGHT injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adjudicated serious hypersensitivity reactions	Evaluate the rate of adjudicated serious hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.	75 +/- 15 minutes post LUMISIGHT injection
Incidence of hypersensitivity reactions	Evaluate the rate of hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.	75 +/- 15 minutes post LUMISIGHT injection
Distribution of severity of adjudicated hypersensitivity reactions	Evaluate the distribution of adjudicated severity of observed hypersensitivity reactions.	75 +/- 15 minutes post LUMISIGHT injection
Descriptive statistics of population with occurrence of adjudicated anaphylaxis.	Characterize risk factors (e.g. patient characteristics, medical history, duration of drug exposure) associated with the occurrence of adjudicated anaphylaxis among patients exposed to LUMISIGHT.	75 +/- 15 minutes of LUMISIGHT injection
Descriptive statistics of population with occurrence of adjudicated severe hypersensitivity reactions.	Characterize risk factors (e.g. patient characteristics, medical history, duration of drug exposure) associated with the occurrence of adjudicated severe hypersensitivity reaction (Grade ≥ 3) among patients exposed to LUMISIGHT.	75 +/- 15 minutes post LUMISIGHT injection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline is tryptase levels for the population that experiences a hypersensitivity event	Characterize the mechanism of action of hypersensitivity reactions occurring after administration of LUMISIGHT by providing a descriptive analysis for tryptase levels in blood and changes from baseline.	60 days post hypersensitivity reaction

Collaborators and Investigators

• Sponsor: Lumicell, Inc.
• Investigators: Principal Investigator: Jorge Ferrer, PhD, 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

• Prescribing Information for LUMISIGHT
• Lumicell sponsored website for LumiSystem

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; hypersensitivity; drug allergy; anaphylaxis; fluorescence guided surgery; Lumicell; LumiSystem; LUMISIGHT; Intraoperative margin detection; post-market safety
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Immune System Diseases; Hypersensitivity, Immediate; Chemically-Induced Disorders; Skin Diseases; Breast Diseases; Drug-Related Side Effects and Adverse Reactions; Skin and Connective Tissue Diseases; Hypersensitivity; Breast Neoplasms; Anaphylaxis; Drug Hypersensitivity
• Other Study ID Numbers: CLP00203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No