NCT07572162

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Jun 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

4.5 years

First QC Date

April 30, 2026

Last Update Submit

April 30, 2026

Conditions

Hypersensitivity Reactions

Keywords

LumicellLumiSystemLUMISIGHTBreast CancerIntraoperative margin detectionanaphylaxishypersensitivitydrug allergypost-market safetyfluorescence guided surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Incidence of adjudicated serious hypersensitivity reactions

    75 +/- 15 minutes post LUMISIGHT injection

  • Incidence of hypersensitivity reactions

    75 +/- 15 minutes post LUMISIGHT injection

  • Distribution of severity of adjudicated hypersensitivity reactions

    75 +/- 15 minutes post LUMISIGHT injection

  • Descriptive statistics of population with occurrence of adjudicated anaphylaxis.

    75 +/- 15 minutes of LUMISIGHT injection

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

    75 +/- 15 minutes post LUMISIGHT injection

Other Outcomes (1)

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

    60 days post hypersensitivity reaction

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 38320161BACKGROUND

Related Links

MeSH Terms

Conditions

HypersensitivityBreast NeoplasmsAnaphylaxisDrug Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Officials

  • Jorge Ferrer, PhD

    Lumicell, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

VP, Clinical Affairs and Pharmacovigilance

CONTACT

6174041033kate@lumicell.com

Senior Clinical Trial Manager

CONTACT

ppalacios@lumicell.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 7, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

May 7, 2026

Record last verified: 2026-04