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RecruitingNCT07572162Updated Oct 22, 2026

Post-market Safety Study of LUMISIGHT

An observational study in Hypersensitivity Reactions, sponsored by Lumicell, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Primary conditionAnaphylaxisRegistry: HypersensitivityReclassifiedWhy we changed it
Registry
Hypersensitivity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Anaphylaxis
Why
  1. The study's title name Anaphylaxis, a narrower term within Hypersensitivity.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Lumicell, Inc. · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 22, 2026Now RecruitingFirst site in United States+3 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

The LumiSystem is the combination of FDA approved LUMISIGHT (pegulicianine) for injection (NDA 214511) and Lumicell Direct Visualization System (DVS) (PMA P230014). These products 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 post market 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. Additional study objectives are to evaluate the incidence of and characterize other severe hypersensitivity reactions. Study assessments include assessment of adverse events of interest (including laboratory data as indicated in this protocol), physical examination, and assessment of blood pressure, heart rate, and oxygen saturation before and after LUMISIGHT administration. Suspected cases of anaphylaxis and hypersensitivity reactions are adjudicated by a Clinical Endpoint Adjudication Committee according to a standard anaphylaxis definition and hypersensitivity grading system.

02

Conditions studied

  • Hypersensitivity Reactions

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Keywords

  • Lumicell
  • LumiSystem
  • LUMISIGHT
  • Breast Cancer
  • Intraoperative margin detection
  • anaphylaxis
  • hypersensitivity
  • drug allergy
  • post-market safety
  • fluorescence guided surgery
03

In context

Anaphylaxis Reclassified

100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 137 across 48 observational studies indexed under Anaphylaxis.

Browse Anaphylaxis studies →

Lead sponsor

Lumicell, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Compared within Anaphylaxis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years of age or older
  • Has been diagnosed with primary breast cancer and scheduled to undergo a lumpectomy procedure
  • Indicated to receive LUMISIGHT at a dose of 1 mg/kg
  • Willing and able to comply with the study procedures

Exclusion criteria

Exclusion Criteria:

  • History of reactions to pegulicianine.
  • Inability to comply with the requirements of the protocol.
  • Treating physician does not think it is in the best interest of the patient to participate.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Incidence of adjudicated anaphylaxis

    Evaluate the rate of adjudicated anaphylaxis observed within 60-minutes post-injection of LUMISIGHT

    Time frame: 75 +/- 15 minutes post LUMISIGHT injection

Secondary outcomes

  1. Incidence of adjudicated serious hypersensitivity reactions

    Evaluate the rate of adjudicated serious hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.

    Time frame: 75 +/- 15 minutes post LUMISIGHT injection

  2. Incidence of hypersensitivity reactions

    Evaluate the rate of hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.

    Time frame: 75 +/- 15 minutes post LUMISIGHT injection

  3. Distribution of severity of adjudicated hypersensitivity reactions

    Evaluate the distribution of adjudicated severity of observed hypersensitivity reactions.

    Time frame: 75 +/- 15 minutes post LUMISIGHT injection

  4. Descriptive statistics of population with occurrence of adjudicated anaphylaxis.

    Characterize risk factors (e.g. patient characteristics, medical history, duration of drug exposure) associated with the occurrence of adjudicated anaphylaxis among patients exposed to LUMISIGHT.

    Time frame: 75 +/- 15 minutes of LUMISIGHT injection

  5. Descriptive statistics of population with occurrence of adjudicated severe hypersensitivity reactions.

    Characterize risk factors (e.g. patient characteristics, medical history, duration of drug exposure) associated with the occurrence of adjudicated severe hypersensitivity reaction (Grade ≥ 3) among patients exposed to LUMISIGHT.

    Time frame: 75 +/- 15 minutes post LUMISIGHT injection

Other outcomes

  1. Change from baseline is tryptase levels for the population that experiences a hypersensitivity event

    Characterize the mechanism of action of hypersensitivity reactions occurring after administration of LUMISIGHT by providing a descriptive analysis for tryptase levels in blood and changes from baseline.

    Time frame: 60 days post hypersensitivity reaction

07

Study locations

2 of 2 sites recruiting
08

References and documents

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 ↗
09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Sep 2026 (actual). Primary completion is estimated for Dec 2030, 51 months after the start.

Start moved once since we started tracking on Sep 25, 2026: Jun 2026 → Sep 2026, on Oct 14, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2026
First posted
May 7, 2026
StartActual
Sep 30, 2026was Jun 2026
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 14, 2026
Sites
2 sites added — first site in United States
Show 2 added (2 United States)
  • Stanford University · Palo Alto, United States
  • University of South Alabama Health · Mobile, United States
across 2 updates, Oct 14, 2026 – Oct 22, 2026
Start date
Jun 2026→Sep 30, 2026 (actual)
Oct 14, 2026
Contact
Study contact's phone or email changed: p•••@lumicell.com→w•••@lumicell.com. See the current contact
Oct 14, 2026
Show all 2 updates
  1. Oct 22, 2026
    1 site added
    Show site
    • University of South Alabama Health · Mobile, United States
  2. Oct 14, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United States
    Show site
    • Stanford University · Palo Alto, United States
    Start date Jun 2026→Sep 30, 2026 (now actual)
    Contact Study contact's phone or email changed: p•••@lumicell.com→w•••@lumicell.com. See the current contact
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07572162
Lead sponsor
Lumicell, Inc.
Responsible party
Sponsor
First posted
May 7, 2026
Start date
Sep 30, 2026
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Oct 22, 2026

Study contacts

VP, Clinical Affairs and Pharmacovigilance
Contact
kate@lumicell.com
6174041033
Senior Clinical Trial Manager
Contact
wchen@lumicell.com
Jorge Ferrer, PhD
principal investigator · Lumicell, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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