Hypersensitivity ReactionsNCT07572162
Post-market Safety Study of LUMISIGHT
An observational study of Hypersensitivity Reactions, run by Lumicell, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersensitivity Reactions
- How many people
- 1,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2026to Dec 2030
- 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: 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.
Who may be able to join
- 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
Who cannot join
- History of hypersensitivity 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Senior Clinical Trial Manager contact
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 Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration
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.
- Conditions
- Hypersensitivity Reactions
- Keywords
- Lumicell, LumiSystem, LUMISIGHT, Breast Cancer, Intraoperative margin detection, anaphylaxis, hypersensitivity, drug allergy, post-market safety, fluorescence guided surgery
- Medical subject headings
- Hypersensitivity, Breast Neoplasms, Anaphylaxis, Drug Hypersensitivity
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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adjudicated anaphylaxis
Evaluate the rate of adjudicated anaphylaxis observed within 60-minutes post-injection of LUMISIGHT
Measured: 75 +/- 15 minutes post LUMISIGHT injection
Secondary outcomes (5)
Incidence of adjudicated serious hypersensitivity reactions
Evaluate the rate of adjudicated serious hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.
Measured: 75 +/- 15 minutes post LUMISIGHT injection
Incidence of hypersensitivity reactions
Evaluate the rate of hypersensitivity reactions observed within 60 minutes post-injection of LUMISIGHT.
Measured: 75 +/- 15 minutes post LUMISIGHT injection
Distribution of severity of adjudicated hypersensitivity reactions
Evaluate the distribution of adjudicated severity of observed hypersensitivity reactions.
Measured: 75 +/- 15 minutes post LUMISIGHT injection
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.
Measured: 75 +/- 15 minutes of LUMISIGHT injection
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.
Measured: 75 +/- 15 minutes post LUMISIGHT injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 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 Hypersensitivity ReactionsStudies 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)
Sponsor and investigators
- Lead sponsor
- Lumicell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge Ferrer, PhD, Principal investigator, Lumicell, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572162
- Sponsor's protocol ID
- CLP00203
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration
- ClinicalTrials.gov ID
- NCT07572162
- Acronym / sponsor ID
- CLP00203
- Conditions
- Hypersensitivity Reactions
- Keywords
- Lumicell, LumiSystem, LUMISIGHT, Breast Cancer, Intraoperative margin detection, anaphylaxis, hypersensitivity, drug allergy
- 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
- 7 May 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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of hypersensitivity 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.
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
Incidence of adjudicated anaphylaxis
Time frame: 75 +/- 15 minutes post LUMISIGHT injection
Evaluate the rate of adjudicated anaphylaxis observed within 60-minutes post-injection of LUMISIGHT
5 secondary outcomes
Incidence of adjudicated serious hypersensitivity reactions
Time frame: 75 +/- 15 minutes post LUMISIGHT injection
Incidence of hypersensitivity reactions
Time frame: 75 +/- 15 minutes post LUMISIGHT injection
Distribution of severity of adjudicated hypersensitivity reactions
Time frame: 75 +/- 15 minutes post LUMISIGHT injection
Descriptive statistics of population with occurrence of adjudicated anaphylaxis.
Time frame: 75 +/- 15 minutes of LUMISIGHT injection
Descriptive statistics of population with occurrence of adjudicated severe hypersensitivity reactions.
Time frame: 75 +/- 15 minutes post LUMISIGHT injection
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.
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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.
Senior Clinical Trial Manager contact
Jorge Ferrer, PhD principal investigator
Lumicell, Inc.
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 Hypersensitivity Reactions, 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 4 inclusion and 3 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 (6174041033, kate@lumicell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adjudicated anaphylaxis (time frame: 75 +/- 15 minutes post LUMISIGHT injection). 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 NCT07572162, 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.