NCT07572162|Recruiting
Post-market Safety Study of LUMISIGHT
Post-market Evaluation of Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration
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Post-market Evaluation of Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration
Sponsor study identifier
observational
1,500
1 country
2
Study Start
September 30, 2026
Actual (reported)Primary Completion
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2026
Actual (reported)May 7, 2026
Actual (reported)September 30, 2026
Actual (reported)December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incidence of adjudicated anaphylaxis
Evaluate the rate of adjudicated anaphylaxis observed within 60-minutes post-injection of LUMISIGHT
75 +/- 15 minutes post LUMISIGHT injection
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
Change from baseline is tryptase levels for the population that experiences a hypersensitivity event
60 days post hypersensitivity reaction
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.
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.
University of South Alabama Health
Mobile, Alabama, 36604, United States
Stanford University
Palo Alto, California, 94304, United States
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.
Jorge Ferrer, PhD
Lumicell, Inc.
First Submitted
April 30, 2026
First Posted
May 7, 2026
Study Start
September 30, 2026
Actual (reported)Primary Completion
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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