What this study is
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.
Study details
- Official title
- Post-market Evaluation of Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration
- Sponsor
- Lumicell, Inc.
- Conditions
- Hypersensitivity Reactions
- Enrolling
- 1,500 people
- Starts
- 2026-09-30
- Est. completion
- 2030-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity of South Alabama Health
Mobile, Alabama, United States
- Tiffany Hill · Contact251-445-3276tnfulford@health.southalabama.edu
- Spencer Liles, MD · Principal investigator
RecruitingStanford University
Palo Alto, California, United States
- Trudy Sea-Eun Kim · Contact(650) 498-1106trudykim@stanford.edu
- Irene Wapnir, MD · Principal investigator
Recruiting
Study team
Sponsor
Lumicell, Inc.
Study ID CLP00203
Principal investigator
Jorge Ferrer, PhD
Lumicell, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.