Post-market Safety Study of LUMISIGHT

Part of paid clinical trials in Palo Alto, California.

Sponsor
Lumicell, Inc.
Study ID
NCT07572162
Status
Recruiting
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Conditions

  • Hypersensitivity Reactions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
May 7, 2026
Start date
Sep 30, 2026
Status verified
Oct 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
1,500 participants (estimated)

Arms

  • Arm: 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

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Trudy Sea-Eun Kim
[email protected]
(650) 498-1106
Irene Wapnir, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University· Palo Alto, CA

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