Post-market Safety Study of LUMISIGHT
NCT07572162 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500
Last updated 2026-05-07
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.
Conditions
- Hypersensitivity Reactions
Sponsors & Collaborators
-
Lumicell, Inc.
lead INDUSTRY
Principal Investigators
-
Jorge Ferrer, PhD · Lumicell, Inc.
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2030-12-31
- Completion
- 2030-12-31
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