Recruiting

LUMISIGHT

Sponsor:

Lumicell, Inc.

Code:

NCT07572162

Conditions

Hypersensitivity Reactions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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

Study ID

NCT07572162

Start date

Sep 30, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Post-market safety population injected with LUMISIGHT

The analysis population consists of the post-market safety population who are injected with LUMISIGHT. The post-market safety population is defined by the indication for use and contraindications as described in the Prescribing Information for LUMISIGHT under NDA 214511.

Primary outcome measure

  • Incidence of adjudicated anaphylaxis [ Time Frame: 75 +/- 15 minutes post LUMISIGHT injection ]

Central Contacts and Locations

Central contacts

VP, Clinical Affairs and Pharmacovigilance

6174041033kate@lumicell.com

Senior Clinical Trial Manager

wchen@lumicell.com

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Trudy Sea-Eun Kim

(650) 498-1106trudykim@stanford.edu

Principal Investigator:

Irene Wapnir, MD

More Information

Sponsor

Lumicell, Inc.

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Keywords

  • Lumicell
  • LumiSystem
  • LUMISIGHT
  • Breast Cancer
  • Intraoperative margin detection
  • anaphylaxis
  • hypersensitivity
  • drug allergy
  • post-market safety
  • fluorescence guided surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by Lumicell, Inc. on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.