Breast CancerIMPACTNCT07616856
Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry
An observational study of Breast Cancer, run by Lumicell, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 1,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2026to Dec 2030
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Participant must be consistent with FDA approved indication
Who cannot join
- Participant is enrolled in a clinical trial using an investigational product directing tissue removal during the lumpectomy procedure
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of South Alabama Health
Mobile, Alabama, 36604
Tiffany Hill, 251-445-3276, tnfulford@health.southalabama.edu
Spencer Liles, MD
- Recruiting
Stanford University
Palo Alto, California, 94304
Trudy Sea-Eun Kim, (650) 498-1106, trudykim@stanford.edu
Irene Wapnir, MD
About this study
Official title: Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Fluorescence guided surgery, intraoperative margin detection, LumiSystem, Lumicell, Lumisight, pegulicianine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post market LumiSystem population consistent with FDA approved labeling | Post market LumiSystem population consistent with FDA approved labeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 7 days
Secondary outcomes (6)
Determine change in margin status after using LumiSystem
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.
Measured: Up to approximately 6 weeks
Determine impact to adjuvant radiotherapy treatment after using LumiSystem.
Proportion of patients whose adjuvant radiotherapy treatment provider reported a change in treatment recommendation or plan due to information received by use of LumiSystem.
Measured: Up to approximately 9 months
Determine impact to surgical intervention after using LumiSystem
Assess clinical utility of LumiSystem use.
Measured: Up to approximately 6 weeks
Compare LumiSystem performance against standard of care (SoC)
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.
Measured: Up to approximately 6 weeks
Report on healthcare utilization for patients undergoing breast conserving surgery (BCS) with LumiSystem.
Change in healthcare utilization associated with use of LumiSystem
Measured: Up to approximately 8 weeks
Identification of safety signals.
Rate of adverse events and adverse device effects.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start30 Sep 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Lumicell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616856
- Sponsor's protocol ID
- CLP00205
- Acronym
- IMPACT
- Status last verified
- Oct 2026
- First submitted
- 21 May 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Two types of summary reports will be generated annually and shared with the site Investigators: i) one report will summarize the overall dataset ii) the second report will include the site's summary data from their own institute including benchmarks relative to the average without disclosure of the results of other institutions. IPD from an institution will be shared with investigators from that institution who request this data for further analysis.
Publications
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.
PubMed 38320161
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility
- ClinicalTrials.gov ID
- NCT07616856
- Acronym / sponsor ID
- IMPACT / CLP00205
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Fluorescence guided surgery, intraoperative margin detection, LumiSystem, Lumicell, Lumisight, pegulicianine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Lumicell, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post market LumiSystem population consistent with FDA approved labeling | – | –Post market LumiSystem population consistent with FDA approved labeling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Participant must be consistent with FDA approved indication
Key exclusion criteria (1 listed)
- Participant is enrolled in a clinical trial using an investigational product directing tissue removal during the lumpectomy procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Determine change in margin status after using LumiSystem
Time frame: Up to approximately 6 weeks
Determine impact to adjuvant radiotherapy treatment after using LumiSystem.
Time frame: Up to approximately 9 months
Determine impact to surgical intervention after using LumiSystem
Time frame: Up to approximately 6 weeks
Compare LumiSystem performance against standard of care (SoC)
Time frame: Up to approximately 6 weeks
Report on healthcare utilization for patients undergoing breast conserving surgery (BCS) with LumiSystem.
Time frame: Up to approximately 8 weeks
Identification of safety signals.
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 38320161Smith 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.
- Individual participant dataSharing planned: Yes. Two types of summary reports will be generated annually and shared with the site Investigators: i) one report will summarize the overall dataset ii) the second report will include the site's summary data from their own institute including benchmarks relative to the average without disclosure of the results of other institutions. IPD from an institution will be shared with investigators from that institution who request this data for further analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Lumicell, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VP, Clinical Affairs and Pharmacovigilance (16174041033, kate@lumicell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize removal of residual cancer in the lumpectomy bed of breast cancer patients. (time frame: Approximately 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07616856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.