Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry

NCT07616856 | Not Yet Recruiting

• 1 other identifier: CLP00205
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Characterize removal of residual cancer in the lumpectomy bed of breast cancer patients.

  Proportion of patients who have residual cancer found in at least one LumiSystem-guided shave among all patients.

  Approximately 7 days

Secondary Outcomes (6)

• Determine change in margin status after using LumiSystem

  Up to approximately 6 weeks

• Determine impact to adjuvant radiotherapy treatment after using LumiSystem.

  Up to approximately 9 months

• Determine impact to surgical intervention after using LumiSystem

  Up to approximately 6 weeks

• Compare LumiSystem performance against standard of care (SoC)

  Up to approximately 6 weeks

• Report on healthcare utilization for patients undergoing breast conserving surgery (BCS) with LumiSystem.

  Up to approximately 8 weeks

Study Arms (1)

Post market LumiSystem population consistent with FDA approved labeling

Post market LumiSystem population consistent with FDA approved labeling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a post-market registry study enrolling participants for whom LumiSystem was used during lumpectomy consistent with the FDA-approved indication for use

You may qualify if:

• Participant must be consistent with FDA approved indication

You may not qualify if:

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

Sponsors & Collaborators

• Lumicell, Inc.: lead

Related Publications (1)

• Smith BL, Hunt KK, Carr D, Blumencranz PW, Hwang ES, Gadd MA, Stone K, Dyess DL, Dodge D, Valente S, Dekhne N, Clark P, Lee MC, Samiian L, Lesnikoski BA, Clark L, Smith KP, Chang M, Harris DK, Schlossberg B, Ferrer J, Wapnir IL. Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery. NEJM Evid. 2023 Jul;2(7):EVIDoa2200333. doi: 10.1056/EVIDoa2200333. Epub 2023 Apr 27.

  PMID: 38320161 BACKGROUND

Related Links

• Lumicell sponsored product website

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

VP, Clinical Affairs and Pharmacovigilance

CONTACT

16174041033; kate@lumicell.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: IPD from an institution will be shared with investigators from that institution who request this data for further analysis.