Post-market Safety Study of LUMISIGHT

Starting soon

Conditions studied: Hypersensitivity Reactions

In brief

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.

Key facts

Study ID

NCT07572162

Run by

Lumicell, Inc.

People needed

1500

Starts

2026-06-01

Expected to finish

2030-12-01

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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