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NCT Number: NCT07572162

Post-market Safety Study of LUMISIGHT

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.

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Key information

Conditions

Hypersensitivity Reactions Anaphylaxis Breast Diseases Breast Neoplasms Chemically-Induced Disorders Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of adjudicated anaphylaxis

    Time frame: 75 +/- 15 minutes post LUMISIGHT injection

    Evaluate the rate of adjudicated anaphylaxis observed within 60-minutes post-injection of LUMISIGHT

Secondary outcomes

  1. Incidence of adjudicated serious hypersensitivity reactions

    Time frame: 75 +/- 15 minutes post LUMISIGHT injection

    Evaluate the rate of adjudicated serious hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.

  2. Incidence of hypersensitivity reactions

    Time frame: 75 +/- 15 minutes post LUMISIGHT injection

    Evaluate the rate of hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.

  3. Distribution of severity of adjudicated hypersensitivity reactions

    Time frame: 75 +/- 15 minutes post LUMISIGHT injection

    Evaluate the distribution of adjudicated severity of observed hypersensitivity reactions.

  4. Descriptive statistics of population with occurrence of adjudicated anaphylaxis.

    Time frame: 75 +/- 15 minutes of LUMISIGHT injection

    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.

  5. Descriptive statistics of population with occurrence of adjudicated severe hypersensitivity reactions.

    Time frame: 75 +/- 15 minutes post LUMISIGHT injection

    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.

Other outcomes

  1. Change from baseline is tryptase levels for the population that experiences a hypersensitivity event

    Time frame: 60 days post hypersensitivity reaction

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Senior Clinical Trial Manager

CONTACT

[email protected]

VP, Clinical Affairs and Pharmacovigilance

CONTACT

[email protected]

6174041033

Sponsors and collaborators

Lead sponsor

Lumicell, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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