Post-market Safety Study of LUMISIGHT

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Enrollment: 1500

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07572162). StuddyBuddy aggregates publicly available trial information.