Recruiting

LumiSystem

Sponsor:

Lumicell, Inc.

Code:

NCT07616856

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a minimal risk post-market registry study conducted at participating clinical institutions that are utilizing LumiSystem consistent with the U.S. Food and Drug Administration (FDA) approved indication for use to collect data on the use of LumiSystem in a real-world setting to support the evaluation of safety, effectiveness, clinical utility (including impact to healthcare utilization and surgical management), and product and quality improvements.

Conditions

Breast Cancer

Study ID

NCT07616856

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:

  • Participant must be consistent with FDA approved indication

Exclusion Criteria:

  • Participant is enrolled in a clinical trial using an investigational product directing tissue removal during the lumpectomy procedure

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Post market LumiSystem population consistent with FDA approved labeling

Post market LumiSystem population consistent with FDA approved labeling

Primary outcome measure

  • Characterize removal of residual cancer in the lumpectomy bed of breast cancer patients. [ Time Frame: Approximately 7 days ]

Central Contacts and Locations

Central contacts

VP, Clinical Affairs and Pharmacovigilance

16174041033kate@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

  • Breast Cancer
  • Fluorescence guided surgery
  • intraoperative margin detection
  • LumiSystem
  • Lumicell
  • Lumisight
  • pegulicianine

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.