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Post-market Safety Study of LUMISIGHT
Post-market Evaluation of Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
Sponsor: Lumicell, Inc. · Participants: 1,500 · Started: Sep 30, 2026
Contact the study team
- VP, Clinical Affairs and Pharmacovigilance · Phone: 6174041033
Official record on ClinicalTrials.gov — NCT07572162
Locations in the U.S.
| Alabama | University of South Alabama Health, Mobile |
| California | Stanford University, Palo Alto |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.