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Clinical Trials in the USA / NCT07572162
Recruiting Observational

Post-market Safety Study of LUMISIGHT

NCT07572162 · tracked via the Priya Life Science USA tracker
Sponsor
Lumicell, Inc
Phase
Observational
Started
2026-09-30
Last updated
2026-10-22

Condition(s) studied

Hypersensitivity Reactions

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of adjudicated anaphylaxis — 75 +/- 15 minutes post LUMISIGHT injection
    Evaluate the rate of adjudicated anaphylaxis observed within 60-minutes post-injection of LUMISIGHT

Trial sites (2)

FacilityCityRegionStatus
University of South Alabama Health Mobile Alabama Recruiting
Stanford University Palo Alto California Recruiting

More Lumicell, Inc. trials in the USA

Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry Recruiting
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07572162 on ClinicalTrials.gov ↗ ← All trials in the USA