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Post-market Safety Study of LUMISIGHT
Sponsor: Lumicell, Inc.
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.
Official title: Post-market Evaluation of Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1500
Start Date
2026-09-30
Completion Date
2030-12
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Locations (1)
Stanford University
Palo Alto, California, United States