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NCT Number: NCT07616856

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Lumicell Inc. has developed LumiSystem, a combination product consisting of LUMISIGHT (pegulicianine), an optical imaging agent, and Lumicell Direct Visualization System (DVS), a fluorescence imaging device. U.S. Food and Drug Administration (FDA) approved this combination product on April 17, 2024, for the following indication for use: LUMISIGHT and Lumicell DVS are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. This registry study aims to enroll patients for whom LumiSystem has been clinically indicated and used commercially. This protocol does not direct patient care. This protocol directs the documentation of information about the care and procedures being provided to patients when using LumiSystem consistent with its approved labeling. This registry study will collect data on the use of LumiSystem in a real-world setting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Approximately 7 days

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

Secondary outcomes

  1. Determine change in margin status after using LumiSystem

    Time frame: Up to approximately 6 weeks

    Proportion of patients with at least one positive margin on the index standard lumpectomy that were converted to final negative margins after usual care due to LumiSystem directed shaves among all patients and Proportion of patients with at least one positive margin on index standard lumpectomy that were converted to final negative margins after usual care due to LumiSystem directed shaves among patients with at least one positive margin on standard lumpectomy.

  2. Determine impact to adjuvant radiotherapy treatment after using LumiSystem.

    Time frame: Up to approximately 9 months

    Proportion of patients whose adjuvant radiotherapy treatment provider reported a change in treatment recommendation or plan due to information received by use of LumiSystem.

  3. Determine impact to surgical intervention after using LumiSystem

    Time frame: Up to approximately 6 weeks

    Assess clinical utility of LumiSystem use.

  4. Compare LumiSystem performance against standard of care (SoC)

    Time frame: Up to approximately 6 weeks

    Proportion of LumiSystem-guided shaves that did not contain residual cancer taken after negative margins vs. proportion of standard of care (SoC) shaves that did not contain residual cancer taken after negative margins and proportion of LumiSystem-guided shaves taken after positive margins among positive margins vs. proportion of SoC shaves after positive margins among positive margins.

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

    Time frame: Up to approximately 8 weeks

    Change in healthcare utilization associated with use of LumiSystem

  6. Identification of safety signals.

    Time frame: 7 days

    Rate of adverse events and adverse device effects.

Study contacts

Contact information is provided by the study sponsor or research team.

VP, Clinical Affairs and Pharmacovigilance

CONTACT

[email protected]

16174041033

Sponsors and collaborators

Lead sponsor

Lumicell, Inc.

Industry

Registry information

Official study title

Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility

Acronym: IMPACT

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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